Regional CAPA / NC Lead, APAC

OLYMPUS SINGAPORE PTE. LTD.

Singapore
**
7+ years in quality within medical devices
3+ years leading capa/nc processes
Expertise in root cause analysis tools
** Olympus Singapore Pte. Ltd. is seeking a Regional CAPA/NC Lead for the APAC region, responsible for overseeing and optimizing Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes. The ideal candidate should have extensive experience in quality management within regulated industries, particularly in medical devices, and possess strong analytical and leadership skills. **

Job Summary

  • This role is responsible for governing and optimizing Corrective & Preventive Action (CAPA) and Nonconformance processes across the APAC region.
  • The candidate will act as a regional subject matter expert, ensuring compliance with global quality system requirements and driving root cause excellence.
  • Key responsibilities include facilitating cross-functional problem-solving sessions and utilizing data analytics tools to assess CAPA effectiveness.

Matching Summary

Match Score: 75

** Olympus Singapore Pte. Ltd. is seeking a Regional CAPA/NC Lead for the APAC region, responsible for overseeing and optimizing Corrective and Preventive Action (CAPA) and Nonconformance (NC) processes. The ideal candidate should have extensive experience in quality management within regulated industries, particularly in medical devices, and possess strong analytical and leadership skills. **

Skills & Requirements

Must-have

  • 7+ years in Quality within medical devices
  • 3+ years leading CAPA/NC processes
  • Expertise in root cause analysis tools
  • Experience with eQMS systems like TrackWise
  • Strong data analysis capability using Power BI

Nice-to-have

  • Ability to influence cross-functional collaboration
  • Proven ability to coach and mentor teams
  • Knowledge of FDA 21 CFR Parts 820
  • Experience supporting regulatory inspections

Key Requirements

  • 7+ years experience in Quality
  • 3+ years leading CAPA/NC
  • Knowledge of ISO 9001 / ISO 13485
  • Experience with FDA regulations

Work Rights

Not specified

Tailored Resume

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