How would a candidate for Quality Systems Manager role answer questions in a med device manufacturing org

#1
I'm a recruiter and need help from the experts with the following questions:

Describe your experience with quality systems, what has been your role, what regulations/standards are you familiar with?

If creating a quality system from scratch, what approach would you take? What would you establish first? (this helps you see how they think, whatever they answer with, they should have a good explanation behind it)

How do you prioritize your work with competing timelines? (This should be an easy one, but they should always be thinking about risk first and how those projects impact the business and the patient)

If you were validating a system or process, how would you establish your sample sizes? (this is another simple one to make sure they know basics of taking a risk based approach)
 
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Tidge

Trusted Information Resource
#3
Without regards to the specific role, I ALWAYS ask/confront candidates for positions at medical device manufacturers on this topic...
How do you prioritize your work with competing timelines?
...but I rephrase the scenario in such a way that there are multiple competing tasks, each with equivalent priority, where each task has been identified as the TOP PRIORITY. What do you do? The candidates are not allowed to dispute the premise of the scenario.

More than any other (non-technical) question, I have found the responses to that question to be the best indicator of future performance. For the record: I allow the candidates the opportunity to try to dispute the premise of the question once, before I notify them that the premise is indisputable... because I also learn something about the candidate from such an interaction.
 

Ronen E

Problem Solver
Moderator
#5
I'm a recruiter and need help from the experts with the following questions:

Describe your experience with quality systems, what has been your role, what regulations/standards are you familiar with?

If creating a quality system from scratch, what approach would you take? What would you establish first? (this helps you see how they think, whatever they answer with, they should have a good explanation behind it)

How do you prioritize your work with competing timelines? (This should be an easy one, but they should always be thinking about risk first and how those projects impact the business and the patient)

If you were validating a system or process, how would you establish your sample sizes? (this is another simple one to make sure they know basics of taking a risk based approach)
In my opinion it doesn't matter what they'll answer. regardless of what recruiters think, there's no good way to really know how a person will perform at the role until they actually have a go. There are some loose predictors that can reduce the recruitment risk (i.e. hiring the wrong person) but in my opinion they're not in the Q&A department. This is just probing their sales talent/skills.

A little humility has never hurt anyone. Including recruiters and hiring managers.
 

Tidge

Trusted Information Resource
#6
What is your sample size?
Is your analysis sound?
How do you measure performance?
For the first: I have interviewed dozens of applicants for a variety of positions (no Quality Managers, but many for positions in quality department(s).

I can't speak to the second question, except to say that during interviews my HR teammates often say "I like that question." It is a circumstance (competing priorities) that often presents itself (especially in a regulated industry), so it is not as if it is some hypothetical question. I can recall being asked many less sound job interview questions!

For measuring (non-technical) performance: I observe how an eventual hire behaves when confronted with this nearly precise circumstance. The ones who have meltdowns are judged somewhat harshly... after all, they were essentially warned about this circumstance during the interview process. If I am a peer or manager and I have a suspicion (based on the interview, or through observation) that they may not be able to handle this precise circumstance, I do what I can to make it easier for them. Inability to multi-task (or to otherwise be aware of multiple tasks) is not a disqualifying factor when ranking associates by level-of-performance, but having to hand-hold an associate (or deal with meltdowns) typically diminishes my perception of employee performance.

I see the interview as equally informative for the candidate, the team, and the manager. (less so for the recruiter)
 

John Broomfield

Leader
Super Moderator
#7
First obtain a specification of the required competencies from your client.

These may be specified as the abilities, skills and knowledge necessary to do the job well.

Then you’ll have some idea of the evidence you seek before putting forward any candidate for your client's interviews and selection.
 

Ronen E

Problem Solver
Moderator
#8
For the first: I have interviewed dozens of applicants for a variety of positions (no Quality Managers, but many for positions in quality department(s).

I can't speak to the second question, except to say that during interviews my HR teammates often say "I like that question." It is a circumstance (competing priorities) that often presents itself (especially in a regulated industry), so it is not as if it is some hypothetical question. I can recall being asked many less sound job interview questions!

For measuring (non-technical) performance: I observe how an eventual hire behaves when confronted with this nearly precise circumstance. The ones who have meltdowns are judged somewhat harshly... after all, they were essentially warned about this circumstance during the interview process. If I am a peer or manager and I have a suspicion (based on the interview, or through observation) that they may not be able to handle this precise circumstance, I do what I can to make it easier for them. Inability to multi-task (or to otherwise be aware of multiple tasks) is not a disqualifying factor when ranking associates by level-of-performance, but having to hand-hold an associate (or deal with meltdowns) typically diminishes my perception of employee performance.

I see the interview as equally informative for the candidate, the team, and the manager. (less so for the recruiter)
Thank for replying.

To the first: I meant the sample of individuals who were asked that question during a job interview, then hired, then observed by you to gauge their performance. The number of candidates interviewed and NOT hired (or hired and not observed later) is irrelevant, because your interaction with them can't support the statement you made about the correlation between how they answered that question and their subsequent performance at the role.

To the second: I didn't think you'd be able to speak to it. It was more a thing to ponder with yourself. The fact that HR say they like your question doesn't mean they really like it in the sense you think they do, and even if they do - what does it mean?... HR staff don't have special access to wisdom or humility. Theoretically they see more cases, but once again - is their analysis sound (do they even care?), and is their sample size really big enough? In my experience, HR's exposure to the hiring lifecycle (cradle to grave) is superficial, since it typically focuses on the generic / soft skills aspects and can't properly factor in the technical / profession-specific ones, and it will thus always be biased.

Handling competing tasks rationally and as effectively as possible is a real (and common) challenge. Meeting it, however, is not always about the incumbent's personality / abilities (or anything else you think you're able to discern during a job interview). There are many disrupting factors that can trip even the most suitable/competent person, and sometimes sheer luck makes all the difference between getting away with it and a total disaster, regardless of planning and the best mitigating techniques. It's a stochastic universe.

On the other hand, asking/expecting someone to handle, without any "loss" or sacrifice, competing tasks which are ALL "top priority" (non negotiable) is a totally different thing. It's a hallmark of bad management and it's unfair. I also think it's borderline unfair to base hiring decisions on such a question in a job interview. What do you expect to hear?... Anything the candidate will say will be a fairytale, or a well-rehearsed BS. You want to know how they behave under grinding pressure? You want to know what their Fight or Flight behaviour looks like? You'll have to either have a very candid, elaborate conversation with their past peers (which you're hardly likely to ever get), or apply some other psychological (or pseudo-psychological) techniques that assess behaviour under extreme/unreasonable pressure, e.g. the ones used in military training. But please don't delude yourself that whatever you observe in a job interview has statistical significance.

To the third: Why the separation between "technical" and "non-technical"? When you hire someone, you want them to be successful in both - that's the only performance metric that matters. Succeeding in one, but not in the other, will in many cases be bad for the person, or the company, or both.

What's your definition of "meltdown"? Do you call it a meltdown when a team member lays out the facts to you, together with their rational analysis, and says "I'm sorry, but I think that there is no practical way to handle all those tasks in parallel, with no loss of any kind, because... <here they will highlight the inevitable clashes>. So either you choose what you are willing to sacrifice, or something random will get sacrificed without you deciding about it."? Is it a sign of "weakness" or incompetence?... I think that it's a sign of rationality, of staying calm under pressure, and above all - of courage, to tell it to the boss as it is (perhaps implying that the boss / upper management is acting unrealistic). Don't get me wrong, I'm all in for the "can-do" attitude; but sometimes the right thing to do is call it in. Sticking to the can-do attitude regardless of reality is just unintelligent.

There's a huge difference between "the ability to multi-task" (in reasonable settings) and the ability - and will - to routinely cope with irrational expectations from bad, stubborn managers (I'm not referring to anyone in specific here). I agree with you that a job interview can also be very informative for the candidate. I would steer clear of any QA/RA management position where the hiring manager implies that they often expect everything to be handled as "top priority", without any losses, regardless of any rational analysis. This is not bad management, it's just no-management.
 
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Tidge

Trusted Information Resource
#9
To the third: Why the separation between "technical" and "non-technical"? When you hire someone, you want them to be successful in both - that's the only performance metric that matters. Succeeding in one, but not in the other, will in many cases be bad for the person, or the company, or both.
As an example of a technical question: When interviewing people for a position where they were expected to diagnose potential electrical problems in-circuit, I would provide a rather simple electrical schematic and ask those who self-reported some skills in this area where they thought they'd connect the ground of the oscilloscope probe. There are plenty of otherwise bright & capable people who really don't have that sort of experience, and given the choice between me dedicating training to an individual or hiring one who knows how to do the technical task, I need to know which one will need extra development time. I also need to know how comfortable someone will be when confronted with a common task that they may be uncertain about. In some technical areas, I have learned specific things from both candidates and eventual hires.

Alternatively: The question about prioritization is more about how work gets done (a non-technical issue), as opposed to doing work (a technical issue).

There's a huge difference between "the ability to multi-task" (in reasonable settings) and the ability - and will - to routinely cope with irrational expectations from bad, stubborn managers (I'm not referring to anyone in specific here). I agree with you that a job interview can also be very informative for the candidate. ... This is not bad management, it's just no-management.
I agree. For my direct reports, I make sure that they have clear priorities, which we establish in a collaborative way. However: I'm not the final authority for them (or myself). I do as much as I can for my team, but the pressure to have competing top priorities is real... not that everything is a top priority, just that there will be times when diverse elements of management establish some different "top priorities". I try to be humble enough to recognize that I may unintentionally pass down such a circumstance without intending to do so... but sometimes I may be required to do so. I also interview candidates for positions other than for my direct structure, so my evaluation of those hires is ultimately limited to how well they treat my team for the necessary interfaces.

Specifically for the QA/RA manager, who may be directly interacting with both regulators and stockholders... I'd like to know how they predict they would react to competing top priorities, especially if I am in their QA/RA structure.

What's your definition of "meltdown"? Do you call it a meltdown when a team member lays out the facts to you, together with their rational analysis, and says "I'm sorry, but I think that there is no practical way to handle all those tasks in parallel, with no loss of any kind, because... <here they will highlight the inevitable clashes>.
That doesn't sound like a meltdown to me. Substitute the word irrational, remove any factual discussion/analysis, skip the apologetic... and we may be on the path towards meltdown.

EDIT: I want to clarify something that may have been read into my post. I don't think I've ever disqualified a candidate based on their response to that question. Competing priorities can be a very stressful circumstance, especially if an employee is unprepared for the possibility. I'm explicitly trying to avoid projecting my hopes for their behavior or doing any mind-reading.
 
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Ronen E

Problem Solver
Moderator
#10
Thanks for an elaborate response.
As an example of a technical question: When interviewing people for a position where they were expected to diagnose potential electrical problems in-circuit, I would provide a rather simple electrical schematic and ask those who self-reported some skills in this area where they thought they'd connect the ground of the oscilloscope probe. There are plenty of otherwise bright & capable people who really don't have that sort of experience, and given the choice between me dedicating training to an individual or hiring one who knows how to do the technical task, I need to know which one will need extra development time. I also need to know how comfortable someone will be when confronted with a common task that they may be uncertain about. In some technical areas, I have learned specific things from both candidates and eventual hires.
I perfectly understand the difference between technical and non-technical. I was in these shoes too. However... while for an electrician position this separation makes a lot of sense, for a QA/RA manager it makes much less. For this role in particular, the line between technical and non-technical is quite blurred. The most important skill-set (or ability) for a QA/RA manager, IMO, is the ability to influence people and effect behaviour/attitude change. For many other roles, I would consider this as a non-technical skill. For the QA/RA manager role, not so much so. Again, my point was that it's not linear. To me, it makes little sense to address these two aspects separately and then combine.
the pressure to have competing top priorities is real...
Sure, that wasn't the point. Competing priorities are a fact of enterprise life. Managing them is a necessity. I was merely protesting the state of mind that all-top priorities is an acceptable business practice, and that the goal is to look for someone who can "handle it" on a regular basis (because no sane person is able, or should agree to do that, IMO). I was also suggesting that a candidate who is "fine with it" is either pretending, to get the job, or is disconnected from reality, or doesn't have a clue what managing a business means, or a combination.
there will be times when diverse elements of management establish some different "top priorities".
This is yet another symptom of bad management. There should be a clear line of decision making, and if a team member can't be sure who makes the final call (or is too scared to ask), this should be addressed rather than leaving it to that person's wits or to good fortune (hoping they will "get it right" enough times to prevent disaster). I think that as mid-level managers (and certainly as members of top management) we have a responsibility to fight this tendency, rather than accepting it as a force of nature. It's part of our professional integrity.
I try to be humble enough to recognize that I may unintentionally pass down such a circumstance without intending to do so... but sometimes I may be required to do so.
Required??? To pass down contradicting priorities? That sounds like an unhealthy org to me, and personally I would think twice about staying there if this happens more than, say, once or twice a year.
I also interview candidates for positions other than for my direct structure, so my evaluation of those hires is ultimately limited to how well they treat my team for the necessary interfaces.
What better treatment for your team (and any other team) could they offer than resisting irrational management practices? If you count on their magical abilities to settle out impossible clashes, you might as well consider that the outcomes may sometimes be not so magical for your team. If there is no rational solution (because the expectations aren't rational), the irrational solution may or may not be in your favour, and I dare say predictability will be low.
I'm explicitly trying to avoid projecting my hopes for their behavior or doing any mind-reading.
If in "projecting" you meant hinting, or otherwise giving away to the candidate what you'd "like to hear" or what the "right answer" is, I'm all in with you (though it's hard, and I humbly accept that I may fail at that). However, if you were talking about an internal process that takes place in your head during the recruitment process, I see nothing wrong with having some expectations (better yet, explicit) about what the "dream candidate" would communicate back. On the contrary, it promotes clarity and focus even if you don't say it out loud (and hopefully, don't give it away unintentionally). Regarding "mind-reading" - I think that if we're being completely honest, we're all trying to exercise some sort of mind reading if we take part in candidate interviewing. That's the whole premise of job interviews, as ridiculous as it might sound! Sad. I think that if we were all completely honest about it, we would've had to scrap job interviews completely, as they currently stand. But we won't, for various reasons. The least we can do, however, is admit to ourselves what we're doing.
 
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