Join Olympus Corporation as the Regional CAPA/NC Lead - APAC, responsible for governing and optimising CAPA and Nonconformance processes across a complex, multi-site, regulated environment.
You will act as the regional subject matter expert (SME), ensuring CAPA/NC processes are compliant, effective, and aligned with global quality system requirements. This role is critical in driving root cause excellence, risk-based decision making, and data-driven continuous improvement across APAC sites.
Key Responsibilities
- Lead and oversee Corrective & Preventive Action (CAPA) and Nonconformance (NC) processes across the APAC region
- Drive consistency and compliance across the full CAPA/NC lifecycle
- Act as a regional Subject Matter Expert, supporting audits, inspections, and regulatory readiness
- Facilitate root cause analysis and cross-functional problem-solving sessions using structured methodologies (5 Whys, Fishbone/Ishikawa, trend analysis)
- Apply data analytics tools (Excel, Power BI, Minitab) to perform trend analysis and assess CAPA effectiveness
- Monitor and improve CAPA KPIs (closure rates, recurrence, overdue actions)
- Coach, mentor, and upskill teams to strengthen quality and analytical capability
- Identify systemic issues and lead continuous improvement initiatives
- Partner with global and regional stakeholders to enhance quality system performance
- Support regulatory inspections and audits, ensuring CAPAs/NCs are robust, traceable, and inspection-ready
- Utilise eQMS platforms (e.g. TrackWise, SAP, Agile) to manage workflows, documentation, and compliance
- Apply data analytics tools (Excel, Power BI, Minitab) to perform trend analysis and assess CAPA effectiveness
- Integrate CAPA outputs into change control, risk management, and continuous improvement frameworks
- Coach and mentor teams to strengthen investigation quality, data integrity, and systemic thinking
What we are looking for:
You are a quality expert and influential leader with strong CAPA/NC experience, with:
- 7+ years in Quality within medical devices or regulated industries
- 3+ years leading CAPA/NC or quality systems
- Knowledge of applicable regulations and standards, such as: FDA 21 CFR Parts 210, 211, 820 or ISO 9001 / ISO 13485
- Skilled at facilitating cross-functional RCA sessions.
- Expertise in root cause analysis tools (5 Whys, Fishbone, etc.)
- Experience with eQMS systems (e.g. TrackWise, SAP, Agile)
- Strong data analysis capability (Excel, Power BI, Minitab)
- Proven ability to influence, coach, and drive cross-functional collaboration
- Experience supporting audit readiness and regulatory inspections
