Regulatory Open Forum

Hello,

I received my RAC (US) last year and would like to outline a certification for 2016.  Aside for RA duties, I also conduct internal quality audits according to ISO 13485, EU MDD and Canadian SOR.  As such, I am considering CQA certification.  Would this be the most valuable or the most helpful?  If not, please share your opinions regarding which QA certification you think is/has been most valuable.

Thank you

Hello,

I received my RAC (US) last year and would like to outline a certification for 2016.  Aside for RA duties, I also conduct internal quality audits according to ISO 13485, EU MDD and Canadian SOR.  As such, I am considering CQA certification.  Would this be the most valuable or the most helpful?  If not, please share your opinions regarding which QA certification you think is/has been most valuable.

Thank you

Hello,

I received my RAC (US) last year and would like to outline a certification for 2016.  Aside for RA duties, I also conduct internal quality audits according to ISO 13485, EU MDD and Canadian SOR.  As such, I am considering CQA certification.  Would this be the most valuable or the most helpful?  If not, please share your opinions regarding which QA certification you think is/has been most valuable.

Thank you

Hello Gretchen,

Congrats on your RAC(US)!

ASQ is well recognized in the industry for quality certifications. CQA is a good choice to learn how to audit, but it won't go into much detail on ISO 13485. You may also consider the Biomedical Auditor Certification (CBA). Another avenue worth exploring is to get your Lead Auditor Certification. You'll want to look for a RABQSA, now Exemplar, certified training program. Most registrar's offer the course as a five full day intensive and they can specialize in ISO 13485. I took mine at QMI SAI Global and it was excellent. I've heard good reviews of BSI's course. 

Good luck!

Hi Gretchen, 

Congrats on earning your RAC! The folks here have given some good advice already. 

Choosing what to do with your time is important - you could focus on additional certifications from ASQ or RAPS, pursuing lead auditor certification (RABQSA, now Exemplar), studying subject matter (individual standards, technical material, statistics, etc), increasing interpersonal effectiveness, adding business knowledge or project management. Other things might include being active in professional societies, taking leadership roles in such, or providing teaching/training.

The best way to decide is to evaluate your current position and skills and consider your career goals. What tools, knowledge, and experience, will help increase your ability to get from here to there? I agree with the folks here - CQA is a good introduction to auditing (for all industries, not just biomedical), but CBA is more industry specific. Also, if you are looking for positions which emphasize auditing as a job responsibility,lead auditor certification trumps the ASQ certs. 

So, the best way to know which certification to pursue is to determine what fits with your career goals. It might or might not be a certification.

Best of luck!

Hello,

I received my RAC (US) last year and would like to outline a certification for 2016.  Aside for RA duties, I also conduct internal quality audits according to ISO 13485, EU MDD and Canadian SOR.  As such, I am considering CQA certification.  Would this be the most valuable or the most helpful?  If not, please share your opinions regarding which QA certification you think is/has been most valuable.

Thank you

I will echo David's comments about career planning. 

Which credential is most valuable or most helpful depends on where you want it to take you, eg, do you want to be a more generic type of RA/QA professional, or do you want to be an auditor?  Or do you want to stay flexible between RA and QA?  And how do you plan to pursue your career (eg, promotion up the ladder from within or by job changes)?  HR tends to value paper credentials more than hiring managers, especially if you are already inside and have proven yourself.  Also, paper credentials tend to carry less real (as opposed to legal) weight in the corporate world than in academia.

Your best resource is probably someone who is doing what you want to do.  Find out what they think is/would be most valuable/helpful to them in their job.