At a Glance
- Tasks: Lead CAPA and Nonconformance processes across APAC, ensuring compliance and driving continuous improvement.
- Company: Join Olympus Corporation, a leader in the medical device industry.
- Benefits: Competitive salary, professional development, and opportunities for impactful work.
- Other info: Dynamic role with opportunities to coach teams and influence quality standards.
- Why this job: Be a key player in enhancing quality systems and making a difference in healthcare.
- Qualifications: 7+ years in Quality, with strong CAPA/NC experience and data analysis skills.
The predicted salary is between 70000 - 90000 £ per year.
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
- 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
Regional CAPA / NC Lead, APAC employer: Olympus
At Olympus Corporation, we pride ourselves on being an exceptional employer that fosters a culture of innovation and continuous improvement. As the Regional CAPA/NC Lead in APAC, you will benefit from a collaborative work environment that encourages professional growth through mentorship and training opportunities, while also being part of a global team dedicated to quality excellence in the medical device industry. Our commitment to employee development, coupled with our focus on compliance and data-driven decision-making, makes Olympus a rewarding place to advance your career.
StudySmarter Expert Advice🤫
We think this is how you could land Regional CAPA / NC Lead, APAC
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work at Olympus or similar companies. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your CAPA/NC knowledge. Be ready to discuss specific examples of how you've driven root cause excellence and continuous improvement in your previous roles.
✨Tip Number 3
Showcase your data analysis skills! Bring along examples of how you've used tools like Excel or Power BI to drive decisions. This will demonstrate your capability to assess CAPA effectiveness and improve KPIs.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the team at Olympus.
We think you need these skills to ace Regional CAPA / NC Lead, APAC
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your CAPA/NC experience and relevant skills. Use keywords from the job description to show we’re on the same page about what you bring to the table.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share specific examples of how you've driven root cause excellence or improved CAPA processes in previous roles. Let us see your passion for quality!
Showcase Your Data Skills:Since data analysis is key for this role, don’t forget to mention your experience with tools like Excel, Power BI, or Minitab. We want to know how you’ve used these tools to make data-driven decisions.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at Olympus
✨Know Your CAPA/NC Inside Out
Make sure you’re well-versed in the CAPA and Nonconformance processes. Brush up on the latest regulations like FDA 21 CFR and ISO standards, as these will likely come up in conversation. Being able to discuss specific examples from your experience will show that you’re not just familiar with the theory but have practical knowledge too.
✨Showcase Your Analytical Skills
Prepare to demonstrate your data analysis capabilities. Familiarise yourself with tools like Excel, Power BI, and Minitab, and be ready to discuss how you've used them in past roles. You might even want to bring along a case study or two where your analytical skills led to significant improvements in CAPA effectiveness.
✨Master Root Cause Analysis Techniques
Since this role involves facilitating root cause analysis sessions, make sure you can confidently explain methodologies like the 5 Whys and Fishbone diagrams. Think of a time when you successfully led a cross-functional RCA session and be prepared to share that story, highlighting your leadership and problem-solving skills.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your decision-making and compliance knowledge. Prepare by thinking through potential challenges you might face in the role and how you would address them. This will not only show your expertise but also your proactive approach to problem-solving in a regulated environment.
