Capa And Nc Site Lead (m/f/d)

Johnson & Johnson MedTech

Aachen, North Rhine-Westphalia, Germany
Base: 75.000 eur to 118.450 eur; bonus/equity: not...
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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 Aachen location. The role requires extensive experience in quality engineering within the medical device sector, focusing on CAPA and NC processes, with responsibilities that include leading investigations, regulatory compliance, and mentoring junior engineers. **

Job Summary

  • This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers.
  • The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness.
  • The CAPA & Nonconformance Site Lead will collaborate with cross-functional teams to resolve quality issues and implement sustainable solutions.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a CAPA & Nonconformance Site Lead for its Aachen location. The role requires extensive experience in quality engineering within the medical device sector, focusing on CAPA and NC processes, with responsibilities that include leading investigations, regulatory compliance, and mentoring junior engineers. **

Salary

Base: 75.000 EUR to 118.450 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • CAPA and Nonconformance process management
  • Root cause analysis methodologies
  • Regulatory compliance in medical devices
  • Quality Management System (QMS) improvement
  • Risk management per ISO 14971
  • Cross-functional team collaboration

Nice-to-have

  • Mentoring and training junior engineers
  • Global harmonization initiatives
  • Experience with electronic QMS platforms
  • Strong leadership and project management
  • Influencing quality culture
  • Complaint handling and post-market surveillance

Key Requirements

  • Bachelor’s degree in Engineering or Life Sciences
  • 5–7 years quality engineering experience
  • Deep understanding of FDA QSR, ISO 13485, EU MDR
  • Certified Quality Engineer or similar preferred
  • Experience managing CAPAs and NCs in regulated environment

Work Rights

Not specified

Tailored Resume

Cover Letter