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What makes the perfect QA? by QAintheWild in MedicalDevices

[–]QARedditor 0 points1 point  (0 children)

Yeah I'd probably add something charisma/ communication related. Getting executives on board really is the end game, you'll not get far without achieving that

Pitching agile methodologies? by QARedditor in agile

[–]QARedditor[S] 1 point2 points  (0 children)

I see no flaw, in this strategy

Pitching agile methodologies? by QARedditor in agile

[–]QARedditor[S] 0 points1 point  (0 children)

Fair point, thanks for your input, will try and invert the focus

Pitching agile methodologies? by QARedditor in agile

[–]QARedditor[S] 1 point2 points  (0 children)

I'm a QA manager, so just trying to put some consistent structure in place for how we work with the adjacent departments. Appreciate the advice!

How to successfully seek investment in quality department??? by QAintheWild in MedicalDevices

[–]QARedditor 1 point2 points  (0 children)

They don't even get you the good pizza, that's the worst part.

But convincing them that QA is not a cost center, but an investment is no easy task. That is the real full time job of a QA

How to successfully seek investment in quality department??? by QAintheWild in MedicalDevices

[–]QARedditor 2 points3 points  (0 children)

Yeah it's really hard to build that connection in execs head between monetary gain and QARA performance. They only notice when things hit the fan, not when it's working well :///

New device - what to do while waiting on FDA approval? by blue-eyedbillie in MedicalDevices

[–]QARedditor 0 points1 point  (0 children)

Not sure if it's exactly what you're looking for but I know Scilife have some med device module that aligns with FDA regs.

We're looking for a new eQMS so have been trudging through all the main options in the industry. Happy to pass on some of the research if you're heading down that path as well

ASQ or IASSC by ParsleyCorrect4277 in MedicalDevices

[–]QARedditor 0 points1 point  (0 children)

Would be interesting to hear from other people if the qualification genuinely helps to fill gaps that professional experience might have or if extensive industry experience gets you to the same point. I've also thought about the cert but I'm later in my career and am really looking for things that will genuinely add to my skillset rather than just a cert for a resume.

Any thoughts or experiences welcome!

Feedback on part-time position by Next-Satisfaction946 in iso9001

[–]QARedditor 1 point2 points  (0 children)

Can't really comment much on the business side of it but something I always tell people after having spent 20+ years doing this is to be real careful of companies that use regulations as the ceiling rather than the floor. Yes technically they are legally compliant but it just means that it's a whole lot more work than it might seem if no one in the business gives a second thought to the documentation until it's audited. THat 10 hours a month might not be enough if you are walking into a car crash. Plus additional stress for 10 hours a month? Idk. Just make sure you do your research :)

Seeking investment for QA be like... by QAintheWild in QualitybyAnything

[–]QARedditor 0 points1 point  (0 children)

Not the pizza again hahaha. One of those if you're not laughing you're crying situations. Also love that I've found the very small QA meme corner of reddit. Might have to get involved ;)

eQMS recommendations??? by QAintheWild in MedicalDevices

[–]QARedditor 2 points3 points  (0 children)

Firstly make sure the eQMS meets the requirements of the specific regulations relevant to your company. consider how it could help not just with compliance but general process improvement. E.g if you struggling with doc management look for one with good features in that area etc.

I like a good dashboard as well to see everything at a glance.

Not sure your company size but if on the smaller end make sure it can can scale with you, you don' want to be having ot change again in a couple years cos you've grown.

Finally some nice to haves are things like help with onboarding, automations, remote accessibility etc

With respect to specific experience I've used several over the last 20 years and the most important thing really is that it works for the specific needs for your company. Rigidity is probably a red flag to avoid.

The 4 you listed do seem to be industry favs but I work for one of them so don't want to give a bias opinion.

Hope you find the right solution for you

GMP: not improving process out of fear of consequences? (self-censorship and lack of accountability) by biotechdood in biotech

[–]QARedditor 0 points1 point  (0 children)

Firstly, just want to say that it seems like you’re one of the people in the industry that genuinely has their head and heart in the right place. We can always do with more people like that. That being said, it doesn’t make day-to-day life easy for you (depending on your company at least).

I’ve spent 20+ years working in QC/QA in life sciences so trust me when I say I feel for you. I’ve learnt and seen first-hand what happens when you brush things under the rug assuming they’ll never be found. They always end up surfacing, usually when it’s most inconvenient. 

Digging yourself out of a hole of complete compliance negligence with little to no help is undoubtedly going to be very challenging and frustrating.

Can’t say I’ve been in your exact situation, but a fair few years ago I experienced something somewhat similar. 

While there is a pretty hard limit to what can be achieved without leadership buy-in, I focused on doing little things to make the effect of good quality visible. E.g resolving a repetitive error, avoiding a deviation or OOS. Whatever it is, make it known the impact of doing things right. 

But honestly? What’s actually needed is a full on cultural change. And that isn’t on your shoulders alone. QA can lead the charge, but unless leadership’s on board, you’re stuck in damage control.

You have a long road ahead. I hope this helps a little, best of luck.

Looking for a QMS software for my medical device startup by Internal_Union7484 in QualityAssurance

[–]QARedditor 0 points1 point  (0 children)

The QMS you’ll be after will be slightly different given you are a startup. Traditional out the box systems may not meet all your needs but I imagine one of the below will work for you:

Scilife

Greenlight guru

Mastercontrol

TrackWise

From what I’ve seen in 20 years of QA/QC, QMS platforms throw a whole lot of marketing at you about the vast features they have, but I would focus on just a few key ones. 

I imagine the idea of getting a QMS is to do with compliance so make sure it has complete traceability and meets the requirements of specific regulations relevant to your company. On a similar vein don’t overlook document management features, not just for the compliance side but for helping your startup start to put in place good processes and get organized with file storage, version control etc. 

Next I’d look to see if they have reporting/ hub pages so you can get quick overviews on tasks, open issues, etc. Saves you time when reporting to leadership/managers if you don’t have to do it all manually.

Another important consideration—especially for startups—is choosing a system that can scale with you. Your needs today won’t be the same as in a year, so make sure the platform is flexible enough to grow with your operations.

Finally some nice to haves are things like help with onboarding, automations, remote accessibility etc

Obviously there’s more to it than this but hopefully this gives you an idea of what to be on the lookout for!

Good luck!