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

J&J FAMILY OF COMPANIES

Aachen, North Rhine-Westphalia, Germany
Base: 75.000 eur to 118.450 eur; bonus/equity: not...
Not specified (considering potential for hybrid work based on travel requirements).
Capa and nonconformance process management
Root cause analysis methodologies
Regulatory compliance in medical devices
Johnson & Johnson is seeking a CAPA & Nonconformance Site Lead in Aachen, Germany, to optimize quality processes within the medical device sector. The ideal candidate will have substantial experience in quality engineering, particularly in CAPA and nonconformance processes, and will play a crucial role in driving 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 company provides an inclusive work environment where each person is considered as an individual and respects diversity and dignity.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a CAPA & Nonconformance Site Lead in Aachen, Germany, to optimize quality processes within the medical device sector. The ideal candidate will have substantial experience in quality engineering, particularly in CAPA and nonconformance processes, and will play a crucial role in driving 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 improvement
  • Cross-functional team 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
  • Leadership in quality culture
  • Familiarity with multiple global regulatory bodies

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
  • Experience managing CAPAs and NCs
  • Certified Quality Engineer or similar preferred
  • Experience with electronic QMS platforms
  • Up to 10% travel required

Work Rights

Not specified

Tailored Resume

Cover Letter