Seeking individual with experience within a medical device, pharmaceutical, or diagnostic testing product manufacturer to join a growing company located in the heart of the Number 1 ranked Biopharma Cluster in the US.

Must be able to:

*** Assess the existing quality system and implement improvements to reduce or eliminate regulatory compliance risks.

*** Conduct internal audits and interface with third party auditors from the FDA and customer organizations.

*** Manage the CAPA (Corrective and Preventive Action) system and manage inputs to CAPA system including - NCMRs (Non Conforming Material Reports), SCARs (Supplier Corrective Action Requests), MRBs (Material Review Boards), Product Investigations, etc.

*** Participate in Post-Market Surveillance (PMS) activities including investigation and reporting of Adverse Events (AEs), performance of Health Hazard Evaluations (HHE), Health Hazard Assessment (HHA), and Health Risk Assessments (HRAs).

*** Initiate Field Safety Corrective Actions (FSCA).

*** Ensure adherence to industry standards including ISO 9000, ISO 13485, and 21 CFR 820.

Qualifications:

*** 5+ years related experience within a medical device manufacturer, pharmaceutical company, diagnostic instrument manufacturer, or similar.

Exceptional compensation package designed around top candidate with six figure salary plus annual bonus for total compensation to $110,000+. Generous paid time off (PTO) offerings with a total of six weeks paid time off including vacations, holidays, and flex days. Competitive health benefits plan including medical coverage, dental, vision, prescriptions, and specialist visits.

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000024006_10007337@jobbank302.com

Please reference #36902137 when responding.

5+ years

Massachusetts

$65,000.00

$115,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024006_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Quality Compliance Specialist Regulatory Affairs Product Quality Engineer Quality Specialist Regulatory Engineer Medical Device Diagnostic Products Pharmaceutical Biotechnology Biotech FDA Food and Drug Administration 21 CFR 820 ISO 9000 ISO 13485 ISO 14971 CAPA Corrective and Preventive Action Post Market Surveillance Post-market Surveillance MDR Medical Device Reporting 21 CFR 803 MRB Materials Review Board Certified Auditor Boston Scientific Instrumentation Laboratory Thermo Fisher Waters

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