Permanent Hire - Need Principal Quality Assurance Engineer in Boston MA

locals candidates only from MA, ME or NH

Full time position

• Position: Principal Quality Assurance Engineer (10+ years in class III medical device needed)
• Location: Greater Boston, MA – need candidates that area in MA, ME, or NH
• Duration: Full-Time, clients W2
  
  

How Many Years With

Overall Design Assurance:

Class III Medical Device

FDA QSR 21 CFR Part 820:

13485

14971:

Principal Quality Assurance Engineer in Greater Boston, MA

A pioneering force in medical device innovation, our client is seeking a seasoned Quality Assurance/Regulatory Affairs (QA/RA) professiona l for the pivotal role of Design Assura nce Lead. This position leads the charge in steering the team through uncharted territories of medical device development.

Responsibilities include owning Design Assurance, orchestrating the Quality Management System (QMS) for global compliance, colla borating seamlessly with New Product Development teams, Managing risks, offering engineering assistance, supervising documentation, participating in the enhancement of Electronic Document Management Systems, and specializing in Quality Management System audits and training programs.

Applicants should possess a bachelor's degree in life sciences or engineering,a long with at least a decade of experience in quality assurance within the medical device field,with a minimum of five yea rs focused on design assurance. Expertise in regulatory submissions,preferably within Class Ill devices, a strong grasp of pertinent regulations, outstanding communication abilities, adaptability,and a commitment to ongoing enhancement are essential qualifications.

If you possess an unyielding passion for innovation, unwavering commitment to excellence,and a desire to shape the future of medical device development, joi n our dynamic tea m and emba rk on a transformative journey in healthcare.