I worked for a regulated (medical device) company as QA/compliance/documentation/so many other roles. I had been there way too long, 15 years… I knew every system and product, I was the person people came to for help fixing their problem.
This place has become incredibly toxic over the last 6 years when we were purchased by someone else and he brought in his friend to be our GM. They valued revenue over all else and through their own actions/words, developed a company wide culture that did not see QMS/Documentation/Compliance as value added. Needless to say I went to work every day feeling unheard, unvalued and unwanted. My boss and I kept finding issues but had no means of making people fix them. I won’t even go into details about how they treated my boss other than the fact she was a manager but not invited or included in any of the manager meetings.
In the last few years we’ve been extremely “lucky” because of covid. Most of our audits have been remote, including our FDA audit. Coming out of audits time after time with little to no findings only cemented the idea that me and my boss were being “dramatic” when we raised the red flag about issues.
I kept telling them that we were one good auditor, who took their job seriously, away from being in trouble that could seriously impact our business.
Well my last week was spent dealing with our ISO recertification audit. This guy was like a dog with a bone, he found issue with every single system he looked at. After the 6th finding I could tell he was feeling conflicted. He asked for our GM and told him how bad of shape we were in and if he issued any more findings he would have to start giving us major findings. Major findings = big deal, they have to be corrected within a certain amount of days and require a follow up audit, this would have resulted in us having our ISO certification lapse and huge financial impact. He really didn’t want that to happen (even more work for him). He also expressed to our GM how serious all this was and that FDA would rip us to sheds.
He wrote us up for a few more things but he combined them with other findings so our number stayed at 6. On the last day you could tell he didn’t want to be there anymore lol
A nice cherry on the cake for me was when he told my bosses boss that I was the only one at the company trained/ certified on ISO 13485 and others that had been making decisions shouldn’t have been. He was aware I was leaving and told me I should train everyone before I left. Lol yeah right.
Though it wasn’t as big of a smack in the face as it could have been, the whole thing made me feel really validated.
TL;DR after 6 years of making me feel like my job was unimportant, my company FINALLY got an auditor who found all the things I’ve been telling them weren’t ok.