Base: $94,000.00 - $151,800.00; bonus/equity: not ...
Capa and nonconformance management
Root cause analysis methodologies
Regulatory compliance with fda qsr and iso 13485
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices with a mission of recovering hearts and saving lives
Job Summary
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices with a mission of recovering hearts and saving lives.
The CAPA & Nonconformance Site Lead role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers.
Employees are eligible for comprehensive benefits including retirement plans, vacation, sick time, parental leave, and participation in the company’s long-term incentive program.
Matching Summary
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices with a mission of recovering hearts and saving lives.
Salary
Base: $94,000.00 - $151,800.00; Bonus/Equity: Not specified; Benefits: Retirement plan, 401(k), long-term incentive program, paid time off
Skills & Requirements
Must-have
CAPA and Nonconformance management
Root cause analysis methodologies
Regulatory compliance with FDA QSR and ISO 13485
Quality Management System (QMS) improvement
Cross-functional collaboration
Risk management per ISO 14971
Electronic QMS platforms
Nice-to-have
Mentoring and training junior engineers
Global harmonization initiatives
Complaint handling and post-market surveillance
Leadership and project management skills
Influencing cross-functional teams
Lean Six Sigma methodologies
Key Requirements
Bachelor’s degree in engineering or Life Sciences
5–7 years quality engineering experience in medical devices
Deep understanding of FDA QSR 21 CFR Part 820 and ISO 13485
Experience managing CAPAs and NCs in regulated environments
Certified Quality Engineer or similar certifications preferred