Director of Quality Assurance (Medical Device)
|Job Id: 19905
|Job Type: Permanent
|Industry: MEDICAL DEVICES
|Worksite Location: Headquarters office
|Location: Brooklyn, NY 11215
High Tech. Caring. Lifesaving.
A few phrases that describe this company and their products…Join this medical revolution!
This medical device company, whose proprietary product has advanced the standard of medical treatments in animals and humans, has a bright future of success and innovation ahead.
To aid in that success and growth, they are searching for a proactive, results driven, and decisive Director of Quality Assurance to join their team.
ABOUT THE ROLE:
In the role of Director of Quality Assurance, you will oversee pre-production (design controls and submission to FDA), production and post-production quality assurance. The Director of Quality Assurance will also be part of regulatory compliance (post market surveillance).
THE RIGHT CANDIDATE HAS:
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Chemistry, Science, Quality Assurance, Engineering, or related scientific discipline.
- 15+ years of experience working with cGMPs in QA /QC for a medical device / pharmaceutical manufacturer.
- Class II or Class III medical device experience
- Director or management experience, with the desire and ability to develop/mentor a team
- Experience with pharmaceutical and medical device test standards (USP, ISO, AAMI, ASTM, and IEC).
- Understanding of ISO 13485 and FDA 21 CFR 820.
- Proficient in the use of MS Office.
WHAT THEY OFFER THEIR EMPLOYEES:
- Attractive salary
- Generous PTO
- Medical, Dental, and Vision Insurance
- Company paid Life and Short-Term Disability Coverage
- 401(k) Retirement Savings Plan with Company Match
- Monthly MetroCard
- Stock Options
WE’RE INTERVIEWING NOW!