Standards

Hi All,


I am a quality engineer at a very small medical device company. We are in the process of hiring a new quality manager. I'm looking for technical questions we can ask during the interview process that will help us figure out how well-versed the applicant is in ISO 13485 and 21CFR820. Any suggestions you have would be much appreciated.


Thanks!


Dana

Hi Dana Schultz‍ - thanks for joining us here & posting a question. I'm going to bring in some members from the Medical Device Division who might be able to give you some suggestions

James Shore‍ , David Manalan‍ , George Marcel‍ Lisa Grosskopf‍ and Susan Peiffer‍ from the Healthcare division.


Best of luck!

Trish

Dana

I'd start with the sample exam questions from the Medical Device Auditor certification. You should be able to locate relevant questions there. I'd also ask for identification of any recent webinars the person may have attended- staying current is important.

I'd also have a copy of the just published Medical Device Auditors Handbook from ASQ Quality Press to create some additional questions.

Hi Dana!


Thank you for reaching out--you are connecting with people who have a wealth of knowledge on this topic. Additionally, David Manalan referenced some great resources in his post.


Specific topics you may consider asking about include differences between 13485:2016 and the 2003 version; where "risk" is discussed in 21 CFR Part 820: and/or what design controls are and why they are important.


Hope this helps and you find an awesome quality manager! Please post again if you have questions or would like more suggestions.


Sincerely,

Lisa

Hello Dana,


Agree with the comments from David and Lisa, I would also look to understand if the applicant has appropriate training/experience for the organization size, regulatory rigor - Class 1, 2, 3 , PMA/510k, and product type. Often there is nuances that are either insignificant, or pose a large learning curve in applying the QMS within an organization. The BOK for CMDA is a great resource as well as basic QMS and quality project deliverable type questions from CQM-OE, CQE , and CRE BOKs.

If you are looking at the EU, a definite MDR/IVDR question or two is definitely warranted. Also, don't forget the update to risk for ISO14971 -2019 and the guidance ISO24971-2020 and tie ins to the QMS. Good luck with the interviews.


Regards,


George Marcel