R&d Capa Manager

Philips UK

Onsite
End-to-end capa execution ownership
Root cause analysis methodologies
Iso 13485 and fda qmsr compliance
This role involves owning the end-to-end execution of R&D CAPAs to ensure timely closure within scope and quality standards

Job Summary

  • This role involves owning the end-to-end execution of R&D CAPAs to ensure timely closure within scope and quality standards.
  • The successful candidate will drive high-quality root cause analysis using structured methodologies like 5 Whys and Fishbone diagrams.
  • Candidates must balance speed and compliance while ensuring CAPAs are closed on time with demonstrated impact on systemic issues.

Matching Summary

This role involves owning the end-to-end execution of R&D CAPAs to ensure timely closure within scope and quality standards.

Skills & Requirements

Must-have

  • End-to-end CAPA execution ownership
  • Root cause analysis methodologies
  • ISO 13485 and FDA QMSR compliance
  • Cross-functional R&D collaboration
  • Regulatory audit inspection readiness

Nice-to-have

  • Advanced statistical methods for analysis
  • Digitalization of quality workflows
  • Continuous improvement mindset
  • Structured problem statement translation
  • Resilience under pressure deadlines

Key Requirements

  • Bachelor's or Master's degree in Engineering or Life Sciences
  • 3-8+ years experience in R&D, Quality, or Design Assurance
  • Hands-on experience with CAPA processes and root cause analysis
  • Familiarity with ISO 13485, FDA QMSR, and MDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter