Capa And Nc Site Lead

Abiomed, part of Johnson & Johnson MedTech

Danvers, Massachusetts, United States
Base: $94,000.00 - $151,800.00; bonus/equity: elig...
Not specified (assumed to be hybrid based on industry standards)
Capa and nonconformance processes
Root cause analysis methodologies
Quality management system (qms)
Abiomed, part of Johnson & Johnson MedTech, is seeking a CAPA and Nonconformance Site Lead to oversee quality systems within a regulated medical device environment in Danvers, Massachusetts. The ideal candidate will have extensive experience in quality engineering, particularly in managing CAPAs and NCs, and will be responsible for driving improvements and ensuring compliance

Job Summary

  • Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies.
  • Serve as a subject matter expert (SME) for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.
  • The anticipated base pay range for this position is : $94,000.00 - $151,800.00

Matching Summary

Match Score: 85

Abiomed, part of Johnson & Johnson MedTech, is seeking a CAPA and Nonconformance Site Lead to oversee quality systems within a regulated medical device environment in Danvers, Massachusetts. The ideal candidate will have extensive experience in quality engineering, particularly in managing CAPAs and NCs, and will be responsible for driving improvements and ensuring compliance.

Salary

Base: $94,000.00 - $151,800.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Eligible for Company benefits

Skills & Requirements

Must-have

  • CAPA and Nonconformance processes
  • Root cause analysis methodologies
  • Quality Management System (QMS)
  • FDA QSR (21 CFR Part 820)
  • ISO 13485
  • EU MDR

Nice-to-have

  • Risk management activities
  • Global harmonization initiatives
  • Complaint handling
  • Post-market surveillance
  • Influence cross-functional teams

Key Requirements

  • Minimum 5–7 years of experience
  • Bachelor’s degree in engineering, Life Sciences, or related field
  • Certified Quality Engineer (CQE)
  • Lean Six Sigma Black Belt

Work Rights

Not specified

Tailored Resume

Cover Letter