Jesse Butts: 0:23

Hey everyone. Thanks for joining me for 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 has a fine arts background. She's now the senior manager of corrective action and preventive action, called CAPA for a major medical device company. Amie has graciously agreed to chat about entering a technical field without a technical education or background. Amie, welcome to the show. Thanks for joining me.

Amie Klager: 0:53

Thanks having me. I'm happy to be here.

Jesse Butts: 0:56

And I, I should mention too, that Amie and I are former coworkers from a medical device company, and I think you are the second former coworker from Hillrom that I've had on the show.

Amie Klager: 1:07

Cool.

Jesse Butts: 1:08

So, Amie, could we start a little bit with an explanation of CAPA, what you're doing now? A little bit about quality assurance, however you wanna tackle that it would be really interesting to hear what, what this type of work is all about.

Amie Klager: 1:23

So I work in CAPA, corrective and preventive action as you said, and it's required in the medical device industry by United States and other countries' regulations that we have a system like this. The system has to look for trouble. When we find trouble, decide if it's big or little. Can I just go fix it and it's not a big deal? Or do I need to fix it in a major way so it never happens again? So by necessity, that CAPA system looks at everything. So we look at manufacturing, we look at design, we look at calibrating instruments. We look at testing values from, say, sterilization. We look at all kinds of different things. Supplier issues. The machine went down and we didn't realize it until a few days later. So it's really fun for me because I get to stick my finger in all the pies and ask a hundred questions. And it's very diverse. We get different kinds of issues. For someone who kind of tends to be a jack of all trades, it's a great place to be in, in my department because I literally get to work with everybody. Design, manufacturing, developing products, clinical research, distribution, sales, complaint handling there's, there's just some required elements that the regs ask for, and CAPA's one of those. We have to monitor all of the sources of quality data and the whole goal of a quality system in the CAPA system in particular is look for trouble, see how things are going and, and fix it. And have an active feedback loop between what you're designing and what ends up happening in the field. And there's a spirit of continuous improvement behind the whole thing. We should be monitoring and improving our processes so the next one we make is even better than the one before that. Has fewer complaints. Has fewer side effects. Has better effectivity. You know, does more for more people.

Jesse Butts: 3:27

I'm curious how you entered this field. And I mentioned earlier that you have a fine arts background. So, so what did you study in college?

Amie Klager: 3:37

So when I started college, I wanted to be an engineer. I wanted to be a chemical engineer. And my first year of college I took 18 hours of chemical engineering classes and was doing fine. And got into an art class though, and a metalsmithing class where I made cool metal stuff with my hands that I could hold and look at. And it was so cool. And in engineering, . I took up to Cal three and I had a pile of papers that talked about gradients and equations and how fast does this bucket fill versus drain, and like all of this high math stuff. And I got an A, but I didn't understand any of it. Meanwhile, I've got a thing that I made in my hand and I felt like I'd unlocked like how the world was made. Like, you know, fence posts are made of metal and metal's not this imutable thing. Like metal can be bent, metal can be weathered and just, all of it seemed like much more cool and direct than what I was doing in, in my engineering studies. I never got into art, though, because I thought that it was marketable. I never thought, I'm going to be a famous painter or where I ended up ceramics. I bet you can't name a single, famous potter. And if you can, that's unusual. So I had always done temping and, you know, office type work throughout college. And so when I finished school with my pottery degree, I got a job across the street from my house as a research assistant at a clinical research company. And having basic administrative skills and being thoughtful and, you know, attention to detail, as they say, and, and asking why moved me up pretty fast within that company. Because I said, You know, I know 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 think at that point said, Oh, this girl's got potential. She's just not pushing paper. She wants to know why. There's something there. And so I advanced within that company. And eventually moved to a sponsor company, a medical device company, that was building out their research department. So I worked there for a while in clinical. They at some point shifted me from clinical to quality because we got what's called a warning letter. The FDA said, You guys are in trouble, and I don't think you're fixing it fast enough. So when that happens, they get everybody from all the departments that can be spared from critical things and say, You work in quality now. You're gonna help us fix this stuff. So I transitioned over to quality then, and I felt so insecure about it because I had barely become a clinical person by accident, because I, all I had was this administrative experience. And being a critical, inquisitive person. Typical clinical people have a biology, a chemistry, a biochem degree. I had an art degree, like never, it never quite fit. But in an administrative role, they don't really care. They care that you have a degree and that you ask questions and that you do a good job. When I got into quality, I thought, Well, I didn't have a educational background to do the clinical work, much less do the quality work. So I had a, an amazing manager at the time who said, Amie, it's not, it's not that complicated. Basically a lot of this is common sense, and you're asking the right kind of questions. And when you ask the engineers these questions, they should be able to explain it to you in terms that you understand of just being a person and a smart person 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 it till you make it. Though she later put it in Aristotle terms of you are that which you repeatedly do, which is a much nicer way to say fake it till you make it.

Jesse Butts: 7:38

I'm curious when you were in that role, like, was the original idea that you would return to research once that warning letter was remediated? Or, , Were you now permanently a member of quality and had to figure out how, how to make that work for you? Like, what was that situation like?

Amie Klager: 7:58

I don't know if they ever had an intention of giving me back to clinical. But it happened at a fortuitous life moment. I had one child before I moved into quality. And the first year of his life, I flew literally 50,000 miles.

Jesse Butts: 8:17

Wow.

Amie Klager: 8:17

Because I was a research monitor. I traveled to doctors' offices. I talked to them, I reviewed their records. I helped train them on studies. I, I had a travel job. And I traveled hard. And I believe that you can leave your husband home with a child under one year old for a while. But when I got pregnant with my second child, I don't think that that would work for our family. So it was very fortuitous timing for me at a point where I had to face, I can't keep doing 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 definitely not a travel job. So do this for a while. Let's see how it goes. And I, I thrived in the quality environment enough that it became permanent pretty easily.

Jesse Butts: 9:08

I'd like to, to pose a hypothetical. Let's say someone is a pretty recent liberal arts grad and they are intrigued by a technical field. And they have the issue of how to get their foot in the door. It sounds like your path was finding a role in a company and demonstrating your abilities and your capacity to learn, to, to be able to move into something where you really flourished. And there was obviously a little bit of, of happy accident there. Is that a path that you would recommend, like finding an institution or an industry that intrigues you and, and just finding maybe not any job, but something that might not be the ideal, but a place to start? Or is there another path that you 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 gonna be a surprise to anybody that if you know, people who know you, they can speak to your discernment, your intelligence, your inquisitive nature, your ability to learn. But I have a couple of my employees came from customer service and that's not the most technical job, and it's, it's a pretty entry level job at our company and they have excelled. They did well there, they transitioned over to CAPA and they've learned and grew, grown. And it's never really held them up. And in fact, what they can tell us, there are occasional problems that come from distribution of stuff. So I would go to my customer service 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, but let's go ask this person. So again, building networks is really important. The other place that most of my team comes from, and this is a feeder to many departments, is complaint handling. So it is a, another entry level, not exactly call center, but close. Like get on the phone and talk to customers or be the second point of contact. Your sales rep calls and describes an issue, record it, write good records, do a good job, you know, ask questions, have a continuous improvement mindset. It's another place where you could get started and get exposure and learn about the products and learn about how it works and the effect on people. So I think those are good starts. Internships, I think there might be, might be other ways to get in, but those are the ones that I've seen most often where people come in without an engineering degree.

Jesse Butts: 12:04

And you mentioned who you know, and I feel like a lot of people hear that and they 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 you can approach that is, I need to meet people. Versus just kind of wallowing in despair that you're not that well connected yet. But I'm curious when you were talking about the customer service and, was it complaint handling? Was that the name of the other? Was there anything that you've seen in those people who did move to your department or other more technical departments, did they have something in, in common 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 they can from there and want to grow into a new role are the ones that end up in my area. I want to say that they're inquisitive, that they want to learn, that they're flexible, that they just want to keep growing, that they feel a sense of responsibility and urgency. But a certain part of me thinks, Well, I'm reflecting my personality back on my team and seeing what I believe are my strengths in them. There might be things that I'm missing. Maybe they have different qualities that I just don't...that I'm not recognizing as much as I should. But technical writing, or just writing, being able to tell a story, being able to write something that makes sense, is free of logical holes and is understandable to people at different levels of technical expertise is also a big factor. If you're not able to write or critique others' writing, it will not be as good. You won't be as successful in, in my role. I don't know how true that is in the more technical areas, but to be honest, they're not gonna hire someone to be a design engineer who doesn't have 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 like post it on some internal job board, as well as, you know, one facing the general public ... are the people who have come from customer service and complaint handling, have they reached out to you? Are they just applying like everybody else? What what's that like? I mean, I'm just I'm just curious if there's a proactive networking that is a big part of those people moving into those positions.

Amie Klager: 14:44

I think there is proactive networking, definitely. I believe your relationships within the business are critical to you getting anything done. Because if you have trust with your partners in other areas, you will get better results. Because when I say, Jesse, I want you to do this thing for me, that you wouldn't normally, 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 in a way that is sound. She's not gonna take some information 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 these relationships, both laterally and then with our employees, I might know that a person is looking for a new role and I might have other people in my network that have openings that might be useful to them. And I can act as a connector between them. So it's proactive networking, not maybe what you meant, like the employee themselves building a network, but tapping into a network and building your own, I guess.

Jesse Butts: 15:53

The companies you've worked for. do they weight internal applicants from different departments more heavily than someone from the outside? Or does that just vary by organization or by hiring manager in your experience?

Amie Klager: 16:10

I think it would vary by hiring manager. In my department, typically we list jobs and we interview multiple people, internal and external. We have the exact same slate of questions in theory that we ask them because there's a fairly structured program around hiring that is meant to drive consistency, I think, and fairness. And so we would give them all basically the same kind of questions. And I would judge internal and external people based on their answers, just as much as I'd probably judge people internally and externally based on their answers. And if I'm on the fence between an internal and an external, I would consult with my internal colleagues who might know the internal candidate and ask for their perspectives on them and whether it'd be a good fit for the job. So we try to be fair and we don't, I think we consciously don't try to weight internals over externals, but it may become a deciding factor depending on where we are.

Jesse Butts: 17:21

We talked a bit about how, customer service, complaint handling can be good inroads. And we talked a bit about CAPA and clinical research as areas where once you have a little bit more experience, you can be in those type of roles. Are there any other roles in, in quality assurance or in manufacturing that you've seen that are still kind of quasi technical in nature and, and won't require, excuse me, don't require a, a specialized degree, for people to consider?

Amie Klager: 18:00

So quality systems, which is the, the backbone of of everything is that we have ways to do things, that we define those, and that we train people on how. That we inspect them from time to time to make sure that we're doing what we said we'd do, i.e., internal audit. And then CAPA, which is to look at, 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 it approved by appropriate people. We have to document what we're doing, what we're changing, and it requires a certain amount of rigor because the regs require it. But the other reason that we do that is because it's good. So if we say that the best way to do this thing is according to these six different steps, we've put some thought into that. And if we're gonna change those steps, we should have a good reason why. And we should say why. So for instance, there was a manufacturing process at my husband's old job where you had to put tin on the ends of these wires. And the work instruction said, do not put tin on more than one wire at a time. And yet you would go to the floor and see an operator putting four wires into the tin at once. And we would say, Well, you're not following your process. That's a problem. You should, you have to follow your process. And they might say ,Why? Well, the reason why is if you're sticking four wires into the tin, the chances of you getting one wire completely covered in this substance 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 make changes, we have to document those changes. We have to store those in a quality system database. We have to keep records of all the stuff we do. So document control is the discipline of how do I manage change processes and how do I execute those? And, you know, I would say the folks there are not probably from a technical degreed area either. And it's another good way to get in the door, I guess. And , if you have potential, be identified as having potential, get progressively larger responsibilities, maybe get special projects and show yourself to be successful at this one little special project, so maybe you get more. And frankly, that's how I went from being a quality engineer to a senior manager is just work hard, be good at stuff, get results, and, you know, let people see that. So that's another place where I've seen people come in.

Jesse Butts: 20:57

I'm curious from your vantage point, what do you like most about working 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 many others, 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 assignment asks for you to make a box and it has to be these dimensions and it has to use these two techniques, and it has to be figurative, let's say. The more constraints that the instructor or the assignment put on you, the easier it is to respond to them. Because you're forced to think creatively in order to meet those things and still like express yourself or still make something that's aesthetically appealing. So, what I like about the clinical and the device world is there's tons of rules. There's all kinds of restrictions and all kinds of guidance on how one must do certain things. And it's, it's not just guidance. It's regulations. The governments expect you to behave a certain way, because if you do that, then you're gonna have safer products and more effective products. And you're gonna build your company's reputation as having good stuff that helps people. So I think what I like best about it is you've got all these rules. You've got all these boxes put around, these constraints around what you can do, and then you still have problems that you have to solve. And so I enjoy that you have to navigate between all of these obstacles to get results and build your relationships and build your reputation and people's trust in you and still, you know, follow the rules. So I, I think it's an interesting challenge in, in that way. The other thing is I didn't ever set out to be a writer. But I would say being a, a good writer is at least a quarter of my job. Just taking information in from people at various degrees of technical, technicality I guess is the word, getting information from people, and telling it back to them in a way that is clear, tells a story, has a narrative and is understandable by people that aren't up to their elbows in the technical details of a process because we get audited all the time. One of our audiences for all of our records is an auditor. They don't know anything about our stuff. They only know, oh, that company makes that thing. They don't come in knowing about how many wires you can tin at a certain time. So you need to be able to extrapolate and, and synthesize, that's the word. You have to synthesize all this information around you and tell it back to them, to your audience, in a meaningful and compelling way and a convincing way, because sometimes you're convincing them, 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. So storytelling and that sort of synthesizing information became really important to me, kind of unexpected.

Jesse Butts: 24:32

Are you still making pottery or ceramics or anything like that your spare time?

Amie Klager: 24:37

So I have started to recently. I mentioned my children. I have three children who are nine, 11, and 13, and they are now old enough to entertain themselves and, you know, take care of their own things and help around the house so that I have time now to do it. So I've started doing pottery again. I do knitting, baking. I have, you know, we all have hobbies. So I haven't been doing creative things a lot until somewhat recently. But it's nice to go back to and remember these skills and ... I walked into the class and they said, Oh, it's been 15 years since you last did this or 10 years? Are you gonna remember how? Well, I definitely remember how. I think I threw like a dozen bowls that day. You do not forget.

Jesse Butts: 25:26

Earlier you mentioned something like most people can't mention a famous potter. And I thought about it a little. I can think of someone who is famous and a potter and that's Seth Rogan. That's the only person that'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 and I'm not sure they're good. They definitely remind me of beginner work, but there is a... he can do a series and you can see the connection between them and like there's a... I'm not sure if it's a message, but you can like understand there's an idea behind it and he's executing it to his abilities. And I think a, interest, a vigor, you know, a desire to be artistic that you can see in those pots. But they, they do remind me of beginner work.

Jesse Butts: 26:23

We've talked quite extensively about some approaches that people can take with, building their network, certain types of jobs that can get their foot in the door at the company that, you know, with a little time and, and good work and building reputation can lead to, to some , some more technical roles that they might be interested. Any other suggestions as we, we wrap this up for people who are interested in the type of work that you've mentioned?

Amie Klager: 26:54

Be willing to learn, ask questions, do your own... I don't wanna say do your own research, but you know, Googling things is very powerful. People drop technical terms. And I say, Oh, I don't know what a whatever matrix is. And I go Google it. And I'm like, Oh I know what that is. That makes sense. Use the people around you, use Google, use textbooks. Like there's tons of information out there and you can speed up your on ramping if you want. Just by, b y asking and finding people who are willing to teach and working with them, asking them questions, finding receptive colleagues.

Jesse Butts: 27:35

All right. Well, Amie, thank you for joining us. This was great.

Amie Klager: 27:38

Thank you, Jesse.