Regional CAPA / NC Lead, APAC

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 ResponsibilitiesLead and oversee Corrective & Preventive Action (CAPA) and Nonconformance (NC) processes across the APAC regionDrive consistency and compliance across the full CAPA/NC lifecycleAct as a regional SME, supporting audits, inspections, and regulatory readinessFacilitate 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 effectivenessMonitor and improve CAPA KPIs (closure rates, recurrence, overdue actions)Coach, mentor, and upskill teams to strengthen quality and analytical capabilityIdentify systemic issues and lead continuous improvement initiativesPartner with global and regional stakeholders to enhance quality system performanceSupport regulatory inspections and audits, ensuring CAPAs/NCs are robust, traceable, and inspection-readyUtilise eQMS platforms (e.g. TrackWise, SAP, Agile) to manage workflows, documentation, and complianceApply data analytics tools (Excel, Power BI, Minitab) to perform trend analysis and assess CAPA effectivenessIntegrate CAPA outputs into change control, risk management, and continuous improvement frameworksCoach and mentor teams to strengthen investigation quality, data integrity, and systemic thinking

About Olympus:Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that makes a positive contribution to society.

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?At Olympus, we are dedicated to fostering a high performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact, and Empathy form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.Lead quality excellence across a diverse APAC regionWork with a global leader in healthcare and medical technologyDrive meaningful impact on compliance, quality, and patient safetyBe part of a culture focused on continuous improvement and innovation

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 13485Skilled 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

Apply Now:To submit your interest in this opportunity, select “Apply for this job”.

In the meantime, follow us on:LinkedIn - Olympus CorporationCompany website - www.olympus.com.au

“We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to Olympus to apply.”

No Agency assistance required at this time.