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The (real) anatomy of QA Manager ↴ They evolve under pressure, fueled by caffeine and the knowledge that something, somewhere, is about to break. Here’s what they’re really made of: → Overactive brain Always 3 steps ahead. "What if this update breaks everything?" - their daily mindset. → Hawk eyes A typo in a 100-page doc? Spotted. A bug no one else saw? Caught. → Selective hearing "Everything is fine!" translates to "There are probably three hidden non-conformities somewhere." → Diplomatic mouth Always starting with, "I’m not being negative, but…" before announcing an impending disaster. → Strong shoulders Carrying audits, complaints, impossible deadlines… without (completely) breaking down. → Multitasking hands One hand writing an audit report, another answering emails, and a third (invisible) holding coffee. → Reinforced immune system Survives endless meetings, last-minute fires, and absurd excuses—without losing (too much) sanity. → Stainless steel heart Resists "Why do we have to do this?" and "We’ve always done it this way!" without a heart attack. → Tireless legs Always moving between departments, dodging salespeople who "just need a minute." → Steady feet Standing firm when management suddenly redefines the process overnight. QA Managers: a mix of superhero, detective, and diplomat… powered by LOT of patience and LOT of caffeine. Who else lives this daily? Bonus for QA & RA Manager in start-up 🙏
I don't agree with your post. I don't think the QA Manager or QA should take all this responsibilities. Every one in the company is responsible for making sure that product quality is maintained at all times. In my experience, majority of QA Managers and personnel have become dictators instead of making sure that processes and procedures have been followed by subject matter expects as documented and if there were deviations or changes to the processes that the risks have been identified and mitigated accordingly. A QA Manager/personnel majority of the time they are not specialist or have training in a particular field whereby they come up with solutions that does not make scientific sense or justification.
I absolutely relate lol EU MDR Compliance! I'd just replace "I’m not being negative, but…" with "According to ISO / SOP / WI / training..." and "..but this decision shall be agreed between all the stakeholders"
How true this is………..
I feel this post so much 🤯
💯 This is painfully accurate! QA Managers don’t just evolve under pressure—we thrive in it (with enough caffeine, of course). 🔍 The “hawk eyes” part? Spot on. We can detect a misaligned comma in a 200-page document before the author even finishes their sentence. 📢 And “diplomatic mouth”? More like professional translator—turning "It’s just a minor issue" into "We’re one step away from a CAPA investigation." 🔧 Add to the list: Time Traveler – somehow, we’re expected to fix yesterday’s problems today while predicting tomorrow’s disasters. Shoutout to my fellow QA & RA warriors who keep the chaos (mostly) under control! Who else feels this on a molecular level? #QualityAssurance #RegulatoryAffairs #MedicalDevices #QAReality #ErazoConsulting
Brings a smile to my face this morning!
We could insert you are loved if everything fits but in case of problems maybe you could be in danger. Anyhow QA Manager need as much as possible a great will to face all internal/external actors!
Is it possible to buy it in poster-quality?!?!?! ❤️ (Honest question!)
Less NC & CAPA Headache | Helping medical device quality teams close records on time, bring metrics back to green & pass audits with confidence
7moEU MDR Compliance you should add 'fractured spine' from bearing most of the blame in audits :D