Sep 23, 2007

Filling those QA positions

Medical Devices Today reports that QA positions are getting hard to fill:

Finding well-trained, highly skilled professionals to fill a variety of quality assurance (QA) positions is proving increasingly difficult for a large number of medical device manufacturers, leading some to encourage people interested in the quality profession to make more use of specialized education and certification programs.

“It just seems like there aren’t enough people to fill the funnel. There’s a big gap,” says Don Middlebrook, VP of regulatory affairs and quality assurance at Pleasanton, Calif.-based Thoratec.


“We have positions – for example, quality engineer [and] quality manager jobs – that sometimes take four or five months or longer to fill.”

We really haven't had good luck hiring full time QA either, for the most part we depend on a couple outside consultants for QA stuff and we hire QC, generally from other industries, and pray that they take to it well enough to be a QA in the future. This QC strategy has pretty much been a total and complete failure to date. We've ended up with people who will sign off on anything and don't do any real checking or questioning of their own. The other thing my company does to make up for this is push QA work off onto design and validation engineers, we have started to wise up to this trick though- a co-engineer wrote a procedure for receiving in some parts, after about seven editing back and forths between various people he got fairly disgruntled for working on something that he felt shouldn't be his job.

Why the QA gap? There are a couple of reasons I can come up with that differ from Thoratec, first off, you need more now, as documentation requirements increase, you need more people to cover it, going from GMP to ISO is a lot of mostly QA work and most every medical device company wants to be ISO now. And second, for a lot of people its not an appealing position, its challenging, and QA can take quite a bit of heat and sometimes it boils down to telling the QA "this is what we're doing, you figure out how to make it work" after they do that, they don't get any credit for their clever regulatory strategy, you need a certain personality type to deal with that well. Also along those lines, some of it is just flat out boring, our QA consultants are pretty gung ho, but things like reviewing software validations make them wild-eyed crazy.

Anyway, I obviously don't have a solution, so until someone figures it out, I guess the engineers will keep getting the work.

QA at work reviewing software documentation.


Willy Grunfeld said...

One possible source for filling the demand,and from my experience most companies simply ignore it, is to hire quality professionals that grew up in non-medical industries. Most require previous experience in a similar job with another medical device manufacturer..what it means that they are searching only under the street lamp. After all a quality professional is just that and there aren't that many industry specific needs that are not similar to other industries.
Just my 2 cents

Andrew Dallas said...

I absolutely agree that it's tough to fill QA positions in the medical device industry. My company, Full Spectrum Software, provides both software development and QA testing/V&V for medical and scientific device leaders. We find a four-month lead time for hiring is very common. What we've found is that it is most important to look for the personality traits that make for an effective QA engineer. Beyond that there must be an effective Quality System in place. Having well defined procedures that adhere to FDA guidelines allows a skilled QA professional to be productive very quickly and reduces the risk that regulatory guidelines are not followed.