July 13, 2022 • 28 mins
Amie studied fine arts with no intention of working professionally in the field. She took office jobs during college, and shortly after graduating parlayed that experience into a full-time job for a clinical research company.
Without a technical background, she was moved to the company’s quality team. And she’s flourished in that discipline ever since.
Amie graciously walks us through the ins and outs of moving to a technical career without the “proper” background or education. She dives into:
- The liberal arts skills to double down on and emphasize.
- Entry-level jobs that can act as a pipeline to technical jobs.
- What hiring managers want to hear — and see — from “nontraditional candidates.”
A liberal arts disposition doesn’t preclude technical aptitude or interest. And with Amie’s insights, you can better convince a hiring manager of that fact.
Where to find Amie
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Jesse Butts (00:23):
Hey everyone.
Thanks for joining mefor another episode.
I'm your host Jesse Butts.
Today we have a bonus episode.
I'm chatting with Amie Klager,a quality assurance leader
in medical devices who hasa fine arts background.
She's now the senior manager ofcorrective action and preventive
action, called CAPA for amajor medical device company.
(00:44):
Amie has graciously agreed tochat about entering a technical
field without a technicaleducation or background.
Amie, welcome to the show.
Thanks for joining me.
Amie Klager (00:53):
Thanks having me.
I'm happy to be here.
Jesse Butts (00:56):
And I, I should mention too, that Amie and I
are former coworkers from amedical device company, and
I think you are the secondformer coworker from Hillrom
that I've had on the show.
Amie Klager (01:07):
Cool.
Jesse Butts (01:08):
So, Amie, could we start a little
bit with an explanation ofCAPA, what you're doing now?
A little bit about qualityassurance, however you wanna
tackle that it would be reallyinteresting to hear what, what
this type of work is all about.
Amie Klager (01:23):
So I work in CAPA, corrective and preventive
action as you said, and it'srequired in the medical device
industry by United States andother countries' regulations
that we have a system like this.
The system has tolook for trouble.
When we find trouble, decideif it's big or little.
Can I just go fix itand it's not a big deal?
(01:44):
Or do I need to fix itin a major way so it
never happens again?
So by necessity, that CAPAsystem looks at everything.
So we look at manufacturing,we look at design, we look
at calibrating instruments.
We look at testing valuesfrom, say, sterilization.
(02:06):
We look at all kindsof different things.
Supplier issues.
The machine went downand we didn't realize it
until a few days later.
So it's really fun for mebecause I get to stick my
finger in all the pies andask a hundred questions.
And it's very diverse.
We get differentkinds of issues.
For someone who kind of tendsto be a jack of all trades, it's
(02:27):
a great place to be in, in mydepartment because I literally
get to work with everybody.
Design, manufacturing,developing products, clinical
research, distribution, sales,complaint handling there's,
there's just some requiredelements that the regs ask
for, and CAPA's one of those.
(02:47):
We have to monitor all ofthe sources of quality data
and the whole goal of aquality system in the CAPA
system in particular is lookfor trouble, see how things
are going and, and fix it.
And have an active feedbackloop between what you're
designing and what endsup happening in the field.
And there's a spirit ofcontinuous improvement
(03:10):
behind the whole thing.
We should be monitoring andimproving our processes so
the next one we make is evenbetter than the one before that.
Has fewer complaints.
Has fewer side effects.
Has better effectivity.
You know, does morefor more people.
Jesse Butts (03:27):
I'm curious how you entered this field.
And I mentioned earlier thatyou have a fine arts background.
So, so what did youstudy in college?
Amie Klager (03:37):
So when I started college, I
wanted to be an engineer.
I wanted to be achemical engineer.
And my first year ofcollege I took 18 hours
of chemical engineeringclasses and was doing fine.
And got into an art classthough, and a metalsmithing
class where I made cool metalstuff with my hands that
(03:57):
I could hold and look at.
And it was so cool.
And in engineering, . I tookup to Cal three and I had a
pile of papers that talkedabout gradients and equations
and how fast does this bucketfill versus drain, and like
all of this high math stuff.
And I got an A, but Ididn't understand any of it.
(04:18):
Meanwhile, I've got a thingthat I made in my hand and
I felt like I'd unlockedlike how the world was made.
Like, you know, fence postsare made of metal and metal's
not this imutable thing.
Like metal can be bent, metalcan be weathered and just, all
of it seemed like much more cooland direct than what I was doing
(04:38):
in, in my engineering studies.
I never got into art,though, because I thought
that it was marketable.
I never thought, I'm goingto be a famous painter or
where I ended up ceramics.
I bet you can't name asingle, famous potter.
And if you can, that's unusual.
So I had always done tempingand, you know, office type
(05:02):
work throughout college.
And so when I finished schoolwith my pottery degree, I got
a job across the street from myhouse as a research assistant
at a clinical research company.
And having basic administrativeskills and being thoughtful
and, you know, attention todetail, as they say, and, and
(05:22):
asking why moved me up prettyfast within that company.
Because I said, You know, Iknow I have to do this form.
But why?
What's it for?
Why does it matter?
Somebody asked for this,why is it important?
And my bosses, I thinkat that point said, Oh,
this girl's got potential.
She's just not pushing paper.
She wants to know why.
(05:42):
There's something there.
And so I advancedwithin that company.
And eventually movedto a sponsor company, a
medical device company,that was building out
their research department.
So I worked there fora while in clinical.
They at some point shiftedme from clinical to quality
because we got what'scalled a warning letter.
(06:05):
The FDA said, You guys arein trouble, and I don't think
you're fixing it fast enough.
So when that happens, theyget everybody from all the
departments that can be sparedfrom critical things and
say, You work in quality now.
You're gonna helpus fix this stuff.
So I transitioned over toquality then, and I felt so
insecure about it because Ihad barely become a clinical
(06:27):
person by accident, becauseI, all I had was this
administrative experience.
And being a critical,inquisitive person.
Typical clinical peoplehave a biology, a
chemistry, a biochem degree.
I had an art degree, likenever, it never quite fit.
But in an administrativerole, they don't really care.
They care that you have a degreeand that you ask questions
(06:49):
and that you do a good job.
When I got into quality, Ithought, Well, I didn't have
a educational background todo the clinical work, much
less do the quality work.
So I had a, an amazing managerat the time who said, Amie, it's
not, it's not that complicated.
Basically a lot of this iscommon sense, and you're asking
(07:10):
the right kind of questions.
And when you ask the engineersthese questions, they should
be able to explain it to youin terms that you understand of
just being a person and a smartperson who asks good questions.
If they can't do that,they're not doing a good job.
So keep doing what you're doing.
Basically, fake ittill you make it.
Though she later put it inAristotle terms of you are
(07:32):
that which you repeatedly do,which is a much nicer way to
say fake it till you make it.
Jesse Butts (07:38):
I'm curious when you were in that role,
like, was the original ideathat you would return to
research once that warningletter was remediated?
Or, , Were you now permanentlya member of quality and
had to figure out how, howto make that work for you?
Like, what was thatsituation like?
Amie Klager (07:58):
I don't know if they ever had an intention of
giving me back to clinical.
But it happened at afortuitous life moment.
I had one child beforeI moved into quality.
And the first year of his life,I flew literally 50,000 miles.
Jesse Butts (08:17):
Wow.
Amie Klager (08:17):
Because I was a research monitor.
I traveled to doctors' offices.
I talked to them, Ireviewed their records.
I helped train them on studies.
I, I had a travel job.
And I traveled hard.
And I believe that you can leaveyour husband home with a child
under one year old for a while.
But when I got pregnant with mysecond child, I don't think that
(08:40):
that would work for our family.
So it was very fortuitoustiming for me at a point where
I had to face, I can't keepdoing a travel job and have
it work with my lifestyle.
That they said, Well,come do this quality thing
that, maybe it's temporary,maybe it's a good fit.
But it's definitelynot a travel job.
So do this for a while.
Let's see how it goes.
(09:01):
And I, I thrived in the qualityenvironment enough that it
became permanent pretty easily.
Jesse Butts (09:08):
I'd like to, to pose a hypothetical.
Let's say someone is apretty recent liberal arts
grad and they are intriguedby a technical field.
And they have the issue of howto get their foot in the door.
It sounds like your path wasfinding a role in a company and
(09:31):
demonstrating your abilities andyour capacity to learn, to, to
be able to move into somethingwhere you really flourished.
And there was obviously a littlebit of, of happy accident there.
Is that a path that you wouldrecommend, like finding an
institution or an industry thatintrigues you and, and just
(09:53):
finding maybe not any job, butsomething that might not be the
ideal, but a place to start?
Or is there another path thatyou would recommend to, to
getting the foot in the door?
Amie Klager (10:06):
I think it's who you know.
I don't think that's gonnabe a surprise to anybody
that if you know, peoplewho know you, they can speak
to your discernment, yourintelligence, your inquisitive
nature, your ability to learn.
But I have a couple of myemployees came from customer
service and that's not the mosttechnical job, and it's, it's
(10:30):
a pretty entry level job at ourcompany and they have excelled.
They did well there, theytransitioned over to CAPA and
they've learned and grew, grown.
And it's neverreally held them up.
And in fact, what they cantell us, there are occasional
(10:50):
problems that come fromdistribution of stuff.
So I would go to my customerservice people and say,
Does this make sense?
They're telling me that the,the tracking system does this.
Does that match your experience?
And they'd say, Yes, butlet's go ask this person.
So again, building networksis really important.
The other place that most ofmy team comes from, and this is
(11:14):
a feeder to many departments,is complaint handling.
So it is a, anotherentry level, not exactly
call center, but close.
Like get on the phone andtalk to customers or be the
second point of contact.
Your sales rep calls anddescribes an issue, record
it, write good records, doa good job, you know, ask
(11:37):
questions, have a continuousimprovement mindset.
It's another place where youcould get started and get
exposure and learn about theproducts and learn about how it
works and the effect on people.
So I think thoseare good starts.
Internships, I think theremight be, might be other
(11:58):
ways to get in, but those arethe ones that I've seen most
often where people come inwithout an engineering degree.
Jesse Butts (12:04):
And you mentioned who you know, and I feel like
a lot of people hear that andthey say, I don't know anybody.
And I felt like I've,I've definitely felt like
that at points in my life.
The other way that youcan approach that is,
I need to meet people.
Versus just kind of wallowingin despair that you're not
that well connected yet.
But I'm curious when youwere talking about the
(12:25):
customer service and, wasit complaint handling?
Was that the name of the other?
Was there anything that you'veseen in those people who did
move to your department or othermore technical departments,
did they have something in, incommon that helped them rise
through the rank so to speak?
Amie Klager (12:43):
People who are succeeding at their area and
have learned all that theycan from there and want to
grow into a new role are theones that end up in my area.
I want to say that they'reinquisitive, that they want to
learn, that they're flexible,that they just want to keep
growing, that they feel a senseof responsibility and urgency.
(13:07):
But a certain part of methinks, Well, I'm reflecting
my personality back on myteam and seeing what I believe
are my strengths in them.
There might be thingsthat I'm missing.
Maybe they have differentqualities that I just
don't...that I'm notrecognizing as much as I should.
But technical writing, or justwriting, being able to tell
a story, being able to writesomething that makes sense,
(13:31):
is free of logical holes andis understandable to people at
different levels of technicalexpertise is also a big factor.
If you're not able to writeor critique others' writing,
it will not be as good.
You won't be as successfulin, in my role.
(13:52):
I don't know how true that isin the more technical areas,
but to be honest, they're notgonna hire someone to be a
design engineer who doesn'thave a technical background.
So probably low risk there.
Jesse Butts (14:03):
You are someone who manages a team and
you hire people, correct?
Amie Klager (14:08):
mm-hmm.
Jesse Butts (14:09):
So when you have a, a vacancy and you.
I, I'm not sure if you likepost it on some internal
job board, as well as, youknow, one facing the general
public ... are the people whohave come from customer service
and complaint handling, havethey reached out to you?
(14:31):
Are they just applyinglike everybody else?
What what's that like?
I mean, I'm just I'mjust curious if there's a
proactive networking that isa big part of those people
moving into those positions.
Amie Klager (14:44):
I think there is proactive
networking, definitely.
I believe your relationshipswithin the business are critical
to you getting anything done.
Because if you have trust withyour partners in other areas,
you will get better results.
Because when I say, Jesse,I want you to do this thing
(15:04):
for me, that you wouldn'tnormally, you'll say, Okay,
I know why she's asking that.
She has a track record.
There's always a good reason.
It's always used ina way that is sound.
She's not gonna take someinformation I give her and
misuse it or misrepresent it.
So yes, . I'll go do that.
And then, you know,we go back and forth.
So as a result of having theserelationships, both laterally
(15:27):
and then with our employees,I might know that a person
is looking for a new role andI might have other people in
my network that have openingsthat might be useful to them.
And I can act as aconnector between them.
So it's proactive networking,not maybe what you meant,
like the employee themselvesbuilding a network, but
(15:49):
tapping into a network andbuilding your own, I guess.
Jesse Butts (15:53):
The companies you've worked for.
do they weight internalapplicants from different
departments more heavily thansomeone from the outside?
Or does that just vary byorganization or by hiring
manager in your experience?
Amie Klager (16:10):
I think it would vary by hiring manager.
In my department, typicallywe list jobs and we
interview multiple people,internal and external.
We have the exact same slateof questions in theory that
we ask them because there'sa fairly structured program
(16:31):
around hiring that ismeant to drive consistency,
I think, and fairness.
And so we would givethem all basically the
same kind of questions.
And I would judge internaland external people based on
their answers, just as muchas I'd probably judge people
internally and externallybased on their answers.
(16:53):
And if I'm on the fence betweenan internal and an external, I
would consult with my internalcolleagues who might know
the internal candidate andask for their perspectives
on them and whether it'dbe a good fit for the job.
So we try to be fair and wedon't, I think we consciously
don't try to weight internalsover externals, but it may
(17:17):
become a deciding factordepending on where we are.
Jesse Butts (17:21):
We talked a bit about how, customer
service, complaint handlingcan be good inroads.
And we talked a bit about CAPAand clinical research as areas
where once you have a littlebit more experience, you can
be in those type of roles.
Are there any other roles in,in quality assurance or in
(17:45):
manufacturing that you've seenthat are still kind of quasi
technical in nature and, andwon't require, excuse me,
don't require a, a specializeddegree, for people to consider?
Amie Klager (18:00):
So quality systems, which is the, the
backbone of of everything isthat we have ways to do things,
that we define those, andthat we train people on how.
That we inspect them fromtime to time to make sure
that we're doing what we saidwe'd do, i.e., internal audit.
(18:23):
And then CAPA, which is to lookat, look for trouble, look for
signals within the processes,quality systems in terms of
training and doc control.
Jesse Butts (18:35):
And sorry, what's doc control?
Amie Klager (18:37):
Doc, document control is when we develop
a process, we have to get itapproved by appropriate people.
We have to document whatwe're doing, what we're
changing, and it requiresa certain amount of rigor
because the regs require it.
But the other reason that wedo that is because it's good.
(18:57):
So if we say that the best wayto do this thing is according to
these six different steps, we'veput some thought into that.
And if we're gonna changethose steps, we should
have a good reason why.
And we should say why.
So for instance, there wasa manufacturing process
at my husband's old jobwhere you had to put tin
(19:19):
on the ends of these wires.
And the work instructionsaid, do not put tin on more
than one wire at a time.
And yet you would goto the floor and see an
operator putting fourwires into the tin at once.
And we would say, Well, you'renot following your process.
That's a problem.
You should, you haveto follow your process.
And they might say ,Why?
(19:40):
Well, the reason why is ifyou're sticking four wires
into the tin, the chancesof you getting one wire
completely covered in thissubstance is lower because
they might touch each other.
So , when we define process,we, we think really hard
about what's going in there.
And then when we makechanges, we have to
document those changes.
We have to store those ina quality system database.
(20:04):
We have to keep recordsof all the stuff we do.
So document control isthe discipline of how do
I manage change processesand how do I execute those?
And, you know, I would saythe folks there are not
probably from a technicaldegreed area either.
And it's another good wayto get in the door, I guess.
(20:25):
And , if you have potential,be identified as having
potential, get progressivelylarger responsibilities, maybe
get special projects and showyourself to be successful
at this one little specialproject, so maybe you get more.
And frankly, that's how Iwent from being a quality
engineer to a senior manageris just work hard, be good at
(20:47):
stuff, get results, and, youknow, let people see that.
So that's another place whereI've seen people come in.
Jesse Butts (20:57):
I'm curious from your vantage point,
what do you like most aboutworking in a technical field?
Amie Klager (21:04):
When you're in an art class and someone says,
draw or create, you know,do anything, make a project.
I at least, and I think manyothers, don't know what to do.
You have no idea.
Like, do anything?
I can do anything I want?
What do I want?
I don't really know.
And if your teacher says,or your instructor, if the
(21:26):
assignment asks for you to makea box and it has to be these
dimensions and it has to usethese two techniques, and it
has to be figurative, let's say.
The more constraints that theinstructor or the assignment
put on you, the easierit is to respond to them.
(21:47):
Because you're forced tothink creatively in order to
meet those things and stilllike express yourself or
still make something that'saesthetically appealing.
So, what I like about theclinical and the device world
is there's tons of rules.
There's all kinds ofrestrictions and all kinds
(22:07):
of guidance on how onemust do certain things.
And it's, it'snot just guidance.
It's regulations.
The governments expect you tobehave a certain way, because
if you do that, then you'regonna have safer products
and more effective products.
And you're gonna build yourcompany's reputation as having
good stuff that helps people.
(22:29):
So I think what I likebest about it is you've
got all these rules.
You've got all these boxesput around, these constraints
around what you can do, andthen you still have problems
that you have to solve.
And so I enjoy that you haveto navigate between all of
these obstacles to get resultsand build your relationships
(22:55):
and build your reputation andpeople's trust in you and still,
you know, follow the rules.
So I, I think it's aninteresting challenge
in, in that way.
The other thing is I didn'tever set out to be a writer.
But I would say beinga, a good writer is at
least a quarter of my job.
Just taking information infrom people at various degrees
(23:19):
of technical, technicality Iguess is the word, getting
information from people, andtelling it back to them in
a way that is clear, tellsa story, has a narrative
and is understandable bypeople that aren't up to
their elbows in the technicaldetails of a process because
(23:41):
we get audited all the time.
One of our audiences for allof our records is an auditor.
They don't know anythingabout our stuff.
They only know, oh, thatcompany makes that thing.
They don't come in knowingabout how many wires you
can tin at a certain time.
So you need to be ableto extrapolate and, and
(24:02):
synthesize, that's the word.
You have to synthesize allthis information around you
and tell it back to them, toyour audience, in a meaningful
and compelling way and aconvincing way, because
sometimes you're convincingthem, No, I have not messed up.
I am doing the right thing.
You should not get mad at me.
You should not shut us down.
(24:23):
So storytelling and that sortof synthesizing information
became really importantto me, kind of unexpected.
Jesse Butts (24:32):
Are you still making pottery or
ceramics or anything likethat your spare time?
Amie Klager (24:37):
So I have started to recently.
I mentioned my children.
I have three children who arenine, 11, and 13, and they are
now old enough to entertainthemselves and, you know,
take care of their own thingsand help around the house so
that I have time now to do it.
So I've starteddoing pottery again.
(24:57):
I do knitting, baking.
I have, you know,we all have hobbies.
So I haven't been doingcreative things a lot
until somewhat recently.
But it's nice to go back toand remember these skills
and ... I walked into theclass and they said, Oh,
it's been 15 years since youlast did this or 10 years?
(25:18):
Are you gonna remember how?
Well, I definitely remember how.
I think I threw like adozen bowls that day.
You do not forget.
Jesse Butts (25:26):
Earlier you mentioned something
like most people can'tmention a famous potter.
And I thought about it a little.
I can think of someonewho is famous and a potter
and that's Seth Rogan.
That's the only personthat's coming to mind.
Amie Klager (25:42):
He has the most adorable pots.
Jesse Butts (25:45):
I haven't really checked them out.
Are they good?
Amie Klager (25:47):
Well, he, he's on Twitter and I would see
his pots on Twitter andI'm not sure they're good.
They definitely remind me ofbeginner work, but there is a...
he can do a series and youcan see the connection between
them and like there's a...
I'm not sure if it's amessage, but you can like
understand there's an ideabehind it and he's executing
(26:10):
it to his abilities.
And I think a, interest, avigor, you know, a desire
to be artistic that youcan see in those pots.
But they, they do remindme of beginner work.
Jesse Butts (26:23):
We've talked quite extensively about some
approaches that people cantake with, building their
network, certain types of jobsthat can get their foot in the
door at the company that, youknow, with a little time and,
and good work and buildingreputation can lead to, to
some , some more technical rolesthat they might be interested.
(26:45):
Any other suggestions as we,we wrap this up for people who
are interested in the type ofwork that you've mentioned?
Amie Klager (26:54):
Be willing to learn, ask
questions, do your own...
I don't wanna say do your ownresearch, but you know, Googling
things is very powerful.
People drop technical terms.
And I say, Oh, I don't knowwhat a whatever matrix is.
And I go Google it.
And I'm like, Oh Iknow what that is.
That makes sense.
Use the people around you,use Google, use textbooks.
(27:16):
Like there's tons of informationout there and you can speed up
your on ramping if you want.
Just by, b y asking andfinding people who are willing
to teach and working withthem, asking them questions,
finding receptive colleagues.
Jesse Butts (27:35):
All right.
Well, Amie, thankyou for joining us.
This was great.
Amie Klager (27:38):
Thank you, Jesse.
Hey everyone.
Thanks for joining mefor another episode.
I'm your host Jesse Butts.
Today we have a bonus episode.
I'm chatting with Amie Klager,a quality assurance leader
in medical devices who hasa fine arts background.
She's now the senior manager ofcorrective action and preventive
action, called CAPA for amajor medical device company.
(00:44):
Amie has graciously agreed tochat about entering a technical
field without a technicaleducation or background.
Amie, welcome to the show.
Thanks for joining me.
Amie Klager (00:53):
Thanks having me.
I'm happy to be here.
Jesse Butts (00:56):
And I, I should mention too, that Amie and I
are former coworkers from amedical device company, and
I think you are the secondformer coworker from Hillrom
that I've had on the show.
Amie Klager (01:07):
Cool.
Jesse Butts (01:08):
So, Amie, could we start a little
bit with an explanation ofCAPA, what you're doing now?
A little bit about qualityassurance, however you wanna
tackle that it would be reallyinteresting to hear what, what
this type of work is all about.
Amie Klager (01:23):
So I work in CAPA, corrective and preventive
action as you said, and it'srequired in the medical device
industry by United States andother countries' regulations
that we have a system like this.
The system has tolook for trouble.
When we find trouble, decideif it's big or little.
Can I just go fix itand it's not a big deal?
(01:44):
Or do I need to fix itin a major way so it
never happens again?
So by necessity, that CAPAsystem looks at everything.
So we look at manufacturing,we look at design, we look
at calibrating instruments.
We look at testing valuesfrom, say, sterilization.
(02:06):
We look at all kindsof different things.
Supplier issues.
The machine went downand we didn't realize it
until a few days later.
So it's really fun for mebecause I get to stick my
finger in all the pies andask a hundred questions.
And it's very diverse.
We get differentkinds of issues.
For someone who kind of tendsto be a jack of all trades, it's
(02:27):
a great place to be in, in mydepartment because I literally
get to work with everybody.
Design, manufacturing,developing products, clinical
research, distribution, sales,complaint handling there's,
there's just some requiredelements that the regs ask
for, and CAPA's one of those.
(02:47):
We have to monitor all ofthe sources of quality data
and the whole goal of aquality system in the CAPA
system in particular is lookfor trouble, see how things
are going and, and fix it.
And have an active feedbackloop between what you're
designing and what endsup happening in the field.
And there's a spirit ofcontinuous improvement
(03:10):
behind the whole thing.
We should be monitoring andimproving our processes so
the next one we make is evenbetter than the one before that.
Has fewer complaints.
Has fewer side effects.
Has better effectivity.
You know, does morefor more people.
Jesse Butts (03:27):
I'm curious how you entered this field.
And I mentioned earlier thatyou have a fine arts background.
So, so what did youstudy in college?
Amie Klager (03:37):
So when I started college, I
wanted to be an engineer.
I wanted to be achemical engineer.
And my first year ofcollege I took 18 hours
of chemical engineeringclasses and was doing fine.
And got into an art classthough, and a metalsmithing
class where I made cool metalstuff with my hands that
(03:57):
I could hold and look at.
And it was so cool.
And in engineering, . I tookup to Cal three and I had a
pile of papers that talkedabout gradients and equations
and how fast does this bucketfill versus drain, and like
all of this high math stuff.
And I got an A, but Ididn't understand any of it.
(04:18):
Meanwhile, I've got a thingthat I made in my hand and
I felt like I'd unlockedlike how the world was made.
Like, you know, fence postsare made of metal and metal's
not this imutable thing.
Like metal can be bent, metalcan be weathered and just, all
of it seemed like much more cooland direct than what I was doing
(04:38):
in, in my engineering studies.
I never got into art,though, because I thought
that it was marketable.
I never thought, I'm goingto be a famous painter or
where I ended up ceramics.
I bet you can't name asingle, famous potter.
And if you can, that's unusual.
So I had always done tempingand, you know, office type
(05:02):
work throughout college.
And so when I finished schoolwith my pottery degree, I got
a job across the street from myhouse as a research assistant
at a clinical research company.
And having basic administrativeskills and being thoughtful
and, you know, attention todetail, as they say, and, and
(05:22):
asking why moved me up prettyfast within that company.
Because I said, You know, Iknow I have to do this form.
But why?
What's it for?
Why does it matter?
Somebody asked for this,why is it important?
And my bosses, I thinkat that point said, Oh,
this girl's got potential.
She's just not pushing paper.
She wants to know why.
(05:42):
There's something there.
And so I advancedwithin that company.
And eventually movedto a sponsor company, a
medical device company,that was building out
their research department.
So I worked there fora while in clinical.
They at some point shiftedme from clinical to quality
because we got what'scalled a warning letter.
(06:05):
The FDA said, You guys arein trouble, and I don't think
you're fixing it fast enough.
So when that happens, theyget everybody from all the
departments that can be sparedfrom critical things and
say, You work in quality now.
You're gonna helpus fix this stuff.
So I transitioned over toquality then, and I felt so
insecure about it because Ihad barely become a clinical
(06:27):
person by accident, becauseI, all I had was this
administrative experience.
And being a critical,inquisitive person.
Typical clinical peoplehave a biology, a
chemistry, a biochem degree.
I had an art degree, likenever, it never quite fit.
But in an administrativerole, they don't really care.
They care that you have a degreeand that you ask questions
(06:49):
and that you do a good job.
When I got into quality, Ithought, Well, I didn't have
a educational background todo the clinical work, much
less do the quality work.
So I had a, an amazing managerat the time who said, Amie, it's
not, it's not that complicated.
Basically a lot of this iscommon sense, and you're asking
(07:10):
the right kind of questions.
And when you ask the engineersthese questions, they should
be able to explain it to youin terms that you understand of
just being a person and a smartperson who asks good questions.
If they can't do that,they're not doing a good job.
So keep doing what you're doing.
Basically, fake ittill you make it.
Though she later put it inAristotle terms of you are
(07:32):
that which you repeatedly do,which is a much nicer way to
say fake it till you make it.
Jesse Butts (07:38):
I'm curious when you were in that role,
like, was the original ideathat you would return to
research once that warningletter was remediated?
Or, , Were you now permanentlya member of quality and
had to figure out how, howto make that work for you?
Like, what was thatsituation like?
Amie Klager (07:58):
I don't know if they ever had an intention of
giving me back to clinical.
But it happened at afortuitous life moment.
I had one child beforeI moved into quality.
And the first year of his life,I flew literally 50,000 miles.
Jesse Butts (08:17):
Wow.
Amie Klager (08:17):
Because I was a research monitor.
I traveled to doctors' offices.
I talked to them, Ireviewed their records.
I helped train them on studies.
I, I had a travel job.
And I traveled hard.
And I believe that you can leaveyour husband home with a child
under one year old for a while.
But when I got pregnant with mysecond child, I don't think that
(08:40):
that would work for our family.
So it was very fortuitoustiming for me at a point where
I had to face, I can't keepdoing a travel job and have
it work with my lifestyle.
That they said, Well,come do this quality thing
that, maybe it's temporary,maybe it's a good fit.
But it's definitelynot a travel job.
So do this for a while.
Let's see how it goes.
(09:01):
And I, I thrived in the qualityenvironment enough that it
became permanent pretty easily.
Jesse Butts (09:08):
I'd like to, to pose a hypothetical.
Let's say someone is apretty recent liberal arts
grad and they are intriguedby a technical field.
And they have the issue of howto get their foot in the door.
It sounds like your path wasfinding a role in a company and
(09:31):
demonstrating your abilities andyour capacity to learn, to, to
be able to move into somethingwhere you really flourished.
And there was obviously a littlebit of, of happy accident there.
Is that a path that you wouldrecommend, like finding an
institution or an industry thatintrigues you and, and just
(09:53):
finding maybe not any job, butsomething that might not be the
ideal, but a place to start?
Or is there another path thatyou would recommend to, to
getting the foot in the door?
Amie Klager (10:06):
I think it's who you know.
I don't think that's gonnabe a surprise to anybody
that if you know, peoplewho know you, they can speak
to your discernment, yourintelligence, your inquisitive
nature, your ability to learn.
But I have a couple of myemployees came from customer
service and that's not the mosttechnical job, and it's, it's
(10:30):
a pretty entry level job at ourcompany and they have excelled.
They did well there, theytransitioned over to CAPA and
they've learned and grew, grown.
And it's neverreally held them up.
And in fact, what they cantell us, there are occasional
(10:50):
problems that come fromdistribution of stuff.
So I would go to my customerservice people and say,
Does this make sense?
They're telling me that the,the tracking system does this.
Does that match your experience?
And they'd say, Yes, butlet's go ask this person.
So again, building networksis really important.
The other place that most ofmy team comes from, and this is
(11:14):
a feeder to many departments,is complaint handling.
So it is a, anotherentry level, not exactly
call center, but close.
Like get on the phone andtalk to customers or be the
second point of contact.
Your sales rep calls anddescribes an issue, record
it, write good records, doa good job, you know, ask
(11:37):
questions, have a continuousimprovement mindset.
It's another place where youcould get started and get
exposure and learn about theproducts and learn about how it
works and the effect on people.
So I think thoseare good starts.
Internships, I think theremight be, might be other
(11:58):
ways to get in, but those arethe ones that I've seen most
often where people come inwithout an engineering degree.
Jesse Butts (12:04):
And you mentioned who you know, and I feel like
a lot of people hear that andthey say, I don't know anybody.
And I felt like I've,I've definitely felt like
that at points in my life.
The other way that youcan approach that is,
I need to meet people.
Versus just kind of wallowingin despair that you're not
that well connected yet.
But I'm curious when youwere talking about the
(12:25):
customer service and, wasit complaint handling?
Was that the name of the other?
Was there anything that you'veseen in those people who did
move to your department or othermore technical departments,
did they have something in, incommon that helped them rise
through the rank so to speak?
Amie Klager (12:43):
People who are succeeding at their area and
have learned all that theycan from there and want to
grow into a new role are theones that end up in my area.
I want to say that they'reinquisitive, that they want to
learn, that they're flexible,that they just want to keep
growing, that they feel a senseof responsibility and urgency.
(13:07):
But a certain part of methinks, Well, I'm reflecting
my personality back on myteam and seeing what I believe
are my strengths in them.
There might be thingsthat I'm missing.
Maybe they have differentqualities that I just
don't...that I'm notrecognizing as much as I should.
But technical writing, or justwriting, being able to tell
a story, being able to writesomething that makes sense,
(13:31):
is free of logical holes andis understandable to people at
different levels of technicalexpertise is also a big factor.
If you're not able to writeor critique others' writing,
it will not be as good.
You won't be as successfulin, in my role.
(13:52):
I don't know how true that isin the more technical areas,
but to be honest, they're notgonna hire someone to be a
design engineer who doesn'thave a technical background.
So probably low risk there.
Jesse Butts (14:03):
You are someone who manages a team and
you hire people, correct?
Amie Klager (14:08):
mm-hmm.
Jesse Butts (14:09):
So when you have a, a vacancy and you.
I, I'm not sure if you likepost it on some internal
job board, as well as, youknow, one facing the general
public ... are the people whohave come from customer service
and complaint handling, havethey reached out to you?
(14:31):
Are they just applyinglike everybody else?
What what's that like?
I mean, I'm just I'mjust curious if there's a
proactive networking that isa big part of those people
moving into those positions.
Amie Klager (14:44):
I think there is proactive
networking, definitely.
I believe your relationshipswithin the business are critical
to you getting anything done.
Because if you have trust withyour partners in other areas,
you will get better results.
Because when I say, Jesse,I want you to do this thing
(15:04):
for me, that you wouldn'tnormally, you'll say, Okay,
I know why she's asking that.
She has a track record.
There's always a good reason.
It's always used ina way that is sound.
She's not gonna take someinformation I give her and
misuse it or misrepresent it.
So yes, . I'll go do that.
And then, you know,we go back and forth.
So as a result of having theserelationships, both laterally
(15:27):
and then with our employees,I might know that a person
is looking for a new role andI might have other people in
my network that have openingsthat might be useful to them.
And I can act as aconnector between them.
So it's proactive networking,not maybe what you meant,
like the employee themselvesbuilding a network, but
(15:49):
tapping into a network andbuilding your own, I guess.
Jesse Butts (15:53):
The companies you've worked for.
do they weight internalapplicants from different
departments more heavily thansomeone from the outside?
Or does that just vary byorganization or by hiring
manager in your experience?
Amie Klager (16:10):
I think it would vary by hiring manager.
In my department, typicallywe list jobs and we
interview multiple people,internal and external.
We have the exact same slateof questions in theory that
we ask them because there'sa fairly structured program
(16:31):
around hiring that ismeant to drive consistency,
I think, and fairness.
And so we would givethem all basically the
same kind of questions.
And I would judge internaland external people based on
their answers, just as muchas I'd probably judge people
internally and externallybased on their answers.
(16:53):
And if I'm on the fence betweenan internal and an external, I
would consult with my internalcolleagues who might know
the internal candidate andask for their perspectives
on them and whether it'dbe a good fit for the job.
So we try to be fair and wedon't, I think we consciously
don't try to weight internalsover externals, but it may
(17:17):
become a deciding factordepending on where we are.
Jesse Butts (17:21):
We talked a bit about how, customer
service, complaint handlingcan be good inroads.
And we talked a bit about CAPAand clinical research as areas
where once you have a littlebit more experience, you can
be in those type of roles.
Are there any other roles in,in quality assurance or in
(17:45):
manufacturing that you've seenthat are still kind of quasi
technical in nature and, andwon't require, excuse me,
don't require a, a specializeddegree, for people to consider?
Amie Klager (18:00):
So quality systems, which is the, the
backbone of of everything isthat we have ways to do things,
that we define those, andthat we train people on how.
That we inspect them fromtime to time to make sure
that we're doing what we saidwe'd do, i.e., internal audit.
(18:23):
And then CAPA, which is to lookat, look for trouble, look for
signals within the processes,quality systems in terms of
training and doc control.
Jesse Butts (18:35):
And sorry, what's doc control?
Amie Klager (18:37):
Doc, document control is when we develop
a process, we have to get itapproved by appropriate people.
We have to document whatwe're doing, what we're
changing, and it requiresa certain amount of rigor
because the regs require it.
But the other reason that wedo that is because it's good.
(18:57):
So if we say that the best wayto do this thing is according to
these six different steps, we'veput some thought into that.
And if we're gonna changethose steps, we should
have a good reason why.
And we should say why.
So for instance, there wasa manufacturing process
at my husband's old jobwhere you had to put tin
(19:19):
on the ends of these wires.
And the work instructionsaid, do not put tin on more
than one wire at a time.
And yet you would goto the floor and see an
operator putting fourwires into the tin at once.
And we would say, Well, you'renot following your process.
That's a problem.
You should, you haveto follow your process.
And they might say ,Why?
(19:40):
Well, the reason why is ifyou're sticking four wires
into the tin, the chancesof you getting one wire
completely covered in thissubstance is lower because
they might touch each other.
So , when we define process,we, we think really hard
about what's going in there.
And then when we makechanges, we have to
document those changes.
We have to store those ina quality system database.
(20:04):
We have to keep recordsof all the stuff we do.
So document control isthe discipline of how do
I manage change processesand how do I execute those?
And, you know, I would saythe folks there are not
probably from a technicaldegreed area either.
And it's another good wayto get in the door, I guess.
(20:25):
And , if you have potential,be identified as having
potential, get progressivelylarger responsibilities, maybe
get special projects and showyourself to be successful
at this one little specialproject, so maybe you get more.
And frankly, that's how Iwent from being a quality
engineer to a senior manageris just work hard, be good at
(20:47):
stuff, get results, and, youknow, let people see that.
So that's another place whereI've seen people come in.
Jesse Butts (20:57):
I'm curious from your vantage point,
what do you like most aboutworking in a technical field?
Amie Klager (21:04):
When you're in an art class and someone says,
draw or create, you know,do anything, make a project.
I at least, and I think manyothers, don't know what to do.
You have no idea.
Like, do anything?
I can do anything I want?
What do I want?
I don't really know.
And if your teacher says,or your instructor, if the
(21:26):
assignment asks for you to makea box and it has to be these
dimensions and it has to usethese two techniques, and it
has to be figurative, let's say.
The more constraints that theinstructor or the assignment
put on you, the easierit is to respond to them.
(21:47):
Because you're forced tothink creatively in order to
meet those things and stilllike express yourself or
still make something that'saesthetically appealing.
So, what I like about theclinical and the device world
is there's tons of rules.
There's all kinds ofrestrictions and all kinds
(22:07):
of guidance on how onemust do certain things.
And it's, it'snot just guidance.
It's regulations.
The governments expect you tobehave a certain way, because
if you do that, then you'regonna have safer products
and more effective products.
And you're gonna build yourcompany's reputation as having
good stuff that helps people.
(22:29):
So I think what I likebest about it is you've
got all these rules.
You've got all these boxesput around, these constraints
around what you can do, andthen you still have problems
that you have to solve.
And so I enjoy that you haveto navigate between all of
these obstacles to get resultsand build your relationships
(22:55):
and build your reputation andpeople's trust in you and still,
you know, follow the rules.
So I, I think it's aninteresting challenge
in, in that way.
The other thing is I didn'tever set out to be a writer.
But I would say beinga, a good writer is at
least a quarter of my job.
Just taking information infrom people at various degrees
(23:19):
of technical, technicality Iguess is the word, getting
information from people, andtelling it back to them in
a way that is clear, tellsa story, has a narrative
and is understandable bypeople that aren't up to
their elbows in the technicaldetails of a process because
(23:41):
we get audited all the time.
One of our audiences for allof our records is an auditor.
They don't know anythingabout our stuff.
They only know, oh, thatcompany makes that thing.
They don't come in knowingabout how many wires you
can tin at a certain time.
So you need to be ableto extrapolate and, and
(24:02):
synthesize, that's the word.
You have to synthesize allthis information around you
and tell it back to them, toyour audience, in a meaningful
and compelling way and aconvincing way, because
sometimes you're convincingthem, No, I have not messed up.
I am doing the right thing.
You should not get mad at me.
You should not shut us down.
(24:23):
So storytelling and that sortof synthesizing information
became really importantto me, kind of unexpected.
Jesse Butts (24:32):
Are you still making pottery or
ceramics or anything likethat your spare time?
Amie Klager (24:37):
So I have started to recently.
I mentioned my children.
I have three children who arenine, 11, and 13, and they are
now old enough to entertainthemselves and, you know,
take care of their own thingsand help around the house so
that I have time now to do it.
So I've starteddoing pottery again.
(24:57):
I do knitting, baking.
I have, you know,we all have hobbies.
So I haven't been doingcreative things a lot
until somewhat recently.
But it's nice to go back toand remember these skills
and ... I walked into theclass and they said, Oh,
it's been 15 years since youlast did this or 10 years?
(25:18):
Are you gonna remember how?
Well, I definitely remember how.
I think I threw like adozen bowls that day.
You do not forget.
Jesse Butts (25:26):
Earlier you mentioned something
like most people can'tmention a famous potter.
And I thought about it a little.
I can think of someonewho is famous and a potter
and that's Seth Rogan.
That's the only personthat's coming to mind.
Amie Klager (25:42):
He has the most adorable pots.
Jesse Butts (25:45):
I haven't really checked them out.
Are they good?
Amie Klager (25:47):
Well, he, he's on Twitter and I would see
his pots on Twitter andI'm not sure they're good.
They definitely remind me ofbeginner work, but there is a...
he can do a series and youcan see the connection between
them and like there's a...
I'm not sure if it's amessage, but you can like
understand there's an ideabehind it and he's executing
(26:10):
it to his abilities.
And I think a, interest, avigor, you know, a desire
to be artistic that youcan see in those pots.
But they, they do remindme of beginner work.
Jesse Butts (26:23):
We've talked quite extensively about some
approaches that people cantake with, building their
network, certain types of jobsthat can get their foot in the
door at the company that, youknow, with a little time and,
and good work and buildingreputation can lead to, to
some , some more technical rolesthat they might be interested.
(26:45):
Any other suggestions as we,we wrap this up for people who
are interested in the type ofwork that you've mentioned?
Amie Klager (26:54):
Be willing to learn, ask
questions, do your own...
I don't wanna say do your ownresearch, but you know, Googling
things is very powerful.
People drop technical terms.
And I say, Oh, I don't knowwhat a whatever matrix is.
And I go Google it.
And I'm like, Oh Iknow what that is.
That makes sense.
Use the people around you,use Google, use textbooks.
(27:16):
Like there's tons of informationout there and you can speed up
your on ramping if you want.
Just by, b y asking andfinding people who are willing
to teach and working withthem, asking them questions,
finding receptive colleagues.
Jesse Butts (27:35):
All right.
Well, Amie, thankyou for joining us.
This was great.
Amie Klager (27:38):
Thank you, Jesse.
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