Senior Quality Compliance Specialist

Philips

Alajuela, Costa Rica
Fully remote
Capa investigations end-to-end execution
Root cause analysis using 5 whys ishikawa
Fda regulated manufacturing environment experience
The role involves leading complex root cause analysis and quality problem solving to ensure sustained compliance

Job Summary

  • The role involves leading complex root cause analysis and quality problem solving to ensure sustained compliance.
  • Candidates must partner cross-functionally with Quality, Engineering, Manufacturing, Service, and Commercial teams to execute timely CAPA actions.
  • Philips is a health technology company built on the belief that every human matters and aims to improve lives globally.

Matching Summary

The role involves leading complex root cause analysis and quality problem solving to ensure sustained compliance.

Skills & Requirements

Must-have

  • CAPA investigations end-to-end execution
  • Root cause analysis using 5 Whys Ishikawa
  • FDA regulated manufacturing environment experience
  • 21 CFR Parts 803 806 and 820 knowledge
  • ISO13485 EUMDR and ISO9001 standards

Nice-to-have

  • Cross-functional partnership with Engineering teams
  • Proactive compliance intervention strategies
  • Mentoring teams on QMS best practices
  • Advanced level communication in English

Key Requirements

  • Minimum 5 years FDA regulated experience
  • Bachelor's Degree in Engineering or Sciences
  • Ability to commute to Alajuela Costa Rica

Work Rights

Not specified

Tailored Resume

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