Capa And Nc Site Lead

Johnson & Johnson MedTech

Danvers, Massachusetts, United States
Base: $94,000.00 - $151,800.00; bonus/equity: not ...
Not specified, likely on-site due to the nature of the role and location.
Capa and nonconformance process management
Root cause analysis methodologies
Regulatory compliance in medical devices
Johnson & Johnson MedTech is seeking a CAPA & Nonconformance Site Lead for its Abiomed division in Danvers, Massachusetts. This role focuses on leading quality system improvements and ensuring compliance in a regulated medical device environment, while also mentoring junior engineers

Job Summary

  • Abiomed, part of Johnson & Johnson MedTech, is dedicated to recovering hearts and saving lives through innovative medical devices.
  • The CAPA & Non Conformance Site Lead role is instrumental in driving quality system improvements and ensuring global regulatory compliance.
  • Employees are eligible for comprehensive benefits including retirement plans, vacation, sick time, parental leave, and participation in long-term incentive programs.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a CAPA & Nonconformance Site Lead for its Abiomed division in Danvers, Massachusetts. This role focuses on leading quality system improvements and ensuring compliance in a regulated medical device environment, while also mentoring junior engineers.

Salary

Base: $94,000.00 - $151,800.00; Bonus/Equity: Not specified; Benefits: Retirement plan, 401(k), vacation, sick leave, parental leave, long-term incentive program

Skills & Requirements

Must-have

  • CAPA and Nonconformance process management
  • Root cause analysis methodologies
  • Regulatory compliance in medical devices
  • Quality Management System improvement
  • Cross-functional collaboration
  • Risk management according to ISO 14971
  • Electronic QMS platforms experience

Nice-to-have

  • Coaching and mentoring skills
  • Global harmonization initiatives
  • Complaint handling and post-market surveillance
  • Influencing cross-functional teams
  • Strong project management skills
  • Lean Six Sigma methodologies

Key Requirements

  • Bachelor’s degree in engineering or Life Sciences
  • 5–7 years quality engineering experience
  • Deep knowledge of FDA QSR, ISO 13485, EU MDR
  • Certified Quality Engineer or similar preferred
  • Experience with CAPA and NC in regulated environment
  • Proficiency in quality tools like 8D, FMEA, Six Sigma
  • Up to 10% travel required

Work Rights

Not specified

Tailored Resume

Cover Letter