Smith+Nephew is seeking a Quality Assurance Engineer 2 in Pune, India, to lead quality assurance efforts for new product development in medical devices. The ideal candidate will have experience in regulatory compliance, quality systems, and medical device engineering
Job Summary
Provide quality leadership to new product development (NPD) and/or sustaining project teams as the Quality Engineering representative on projects requiring FDA 510k, CE Mark, and international regulatory approval.
Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, MDD / MDR, and NMPA requirements.
Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance.
Matching Summary
Match Score: 85
Smith+Nephew is seeking a Quality Assurance Engineer 2 in Pune, India, to lead quality assurance efforts for new product development in medical devices. The ideal candidate will have experience in regulatory compliance, quality systems, and medical device engineering.
Skills & Requirements
Must-have
Quality leadership for NPD
Verification and validation test methods
Software and design verification
Risk management documentation
Compliance to cGMP, QSR, ISO, IEC
Medical device software validation
Nice-to-have
Agile and inclusive ways of working
Champion best practices
Team-customized mentorship
Employee Inclusion Groups
Key Requirements
B.S. in Electrical, Computer, or Biomedical Engineering or related discipline
M.S. in Engineering preferred
2+ years in medical device industry with B.S. degree
1+ years in medical device industry with M.S. degree
ASQ CQE / CRE (preferred)
Understanding of regulatory requirements (GMP, ISO 13485, ISO 14971, IEC 62304, IEC 60601, MDD/MDR, NMPA)