Director, Quality Assurance APAC

Overview

Director Quality Assurance APAC

• will be responsible for managing the APAC quality organization.
• You will ensure high quality standards and compliance with regulatory requirements and internal policies.
• You will be responsible for assessing current systems and practices, identifying gaps and developing comprehensive solutions to harmonize and optimize quality processes across the APAC region.
• What to expect:
• **Lead & Inspire:**
• Coach, develop and mentor our talented Quality team, fostering growth, high performance, and cross-border collaboration.
• **Quality Champion:**
• Advance knowledge of QSRs, ISO 13485, ISO 14971, MDSAP, and IVDR and all relevant regulations—making compliance second nature.
• **Strategic Partner:**
• Collaborate with Regulatory, Operations, R&D, Supply Chain, Legal, and Commercial teams to drive quality objectives and harmonize processes.
• **Continuous Improvement:**
• Lead Lean, Six Sigma, and data-driven initiatives to manage non-conformances, CAPAs, complaints, and post-market surveillance.
• **Voice of the Customer:**
• Embed a customer-centric mindset across the organization, ensuring customer needs are the foundation of every quality activity.
• **Regulatory Interface:**
• Act as primary contact for regulatory authorities, notified bodies, and auditors throughout APAC.
• **Talent Developer:**
• Assess organizational structure, address skill gaps, and coach team members to build a world-class quality function.
• **Risk Manager:**
• Proactively identify and mitigate quality risks, staying ahead of regulatory changes and industry best practices.
• **Training & Development:**
• Provide annual training on audit readiness
• What we expect:
• **Experience:**
• A proven track record of building new Quality functions in multiple countries/regions in APAC.

Experience

• working within large, complex organizations.
• Proven experience working with both IVD and medical devices and experience in bringing new products to market.
• **Quality Management Systems:**
• Expertise completing large and small scale harmonization projects.
• **Post Market Surveillance:**

Experience

• creating robust PMS systems.
• **Education:**
• Bachelor’s degree in engineering or a related field required; Master’s (MBA, Quality Management, Engineering) highly preferred.
• **Leadership:**
• Demonstrated success managing large, diverse teams across multiple countries and cultures, Strong and driven leadership skills, including leading other people leaders.
• **Skills:**
• Analytical and strategic thinker.
• Strong problem-solving and decision-making abilities.
• Excellent communicator and influencer at all levels.
• Ability to drive accountability and empower others.
• **Behaviours**
• : Desire and capability to work cross-functionally with sales, service, and marketing teams, including direct interaction with customers as the face of Quality
• **Partnership:**
• Maintain a working knowledge of Hologic's products, and other responsibilities as assigned.
• **Languages:**
• Fluency in English required; additional languages a plus.
• **Travel:**
• Willingness to travel across the APAC region as needed \~15-20%.

Why Join Hologic?

• **Make a Difference:**
• Impact millions of lives by ensuring the highest standards in women’s health and diagnostics.
• **Grow Your Career:**
• Thrive in a global, innovative, and supportive environment.
• **Drive Change:**
• Be part of a company that values your ideas, expertise, and leadership.
• Ready to make your mark?
• Apply now to lead quality excellence at Hologic!