A global B2B medical device manufacturer is seeking a Quality Director to lead and transform the Quality function at its rapidly growing manufacturing site in Chonburi, Thailand. This is a unique opportunity to play a critical role in scaling up a site that is planned to grow from 400 to over 2,000 employees in the next few years.

The company is investing significantly in its Thailand facility, building it into a world-class transfer of its existing China operations. This position will be a key leadership role in driving operational excellence, shaping culture, and elevating site-wide quality performance.

The role reports directly to the Site lead and will manage a team.

Key Responsibilities

• Act as Management Representative for all quality and regulatory matters on site.
• Lead the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant global regulations.
• Direct the overall quality strategy including CAPA, deviations, NCMRs, document control, audits, and supplier quality.
• Collaborate with the engineering and production leaders to align quality with site and corporate goals.
• Lead validation and qualification initiatives for new product introductions and process changes.
• Provide strategic and hands-on leadership to a team of 15–20 quality professionals, including supervisors and managers.
• Represent the site during regulatory and customer audits, and be empowered to stop the production line or shipment in the event of quality concerns.
• Work cross-functionally to build a high-performing quality culture and support operational scalability.

Requirements

• Relevant University degree
• Proven extensive experience in quality and regulatory management within the medical device industry.
• Proven leadership of site-wide quality teams in a manufacturing environment.
• Strong command of FDA, ISO 13485, and global regulatory standards.
• Prior experience handling FDA inspections and non-conformance/CAPA processes is a must.
• Excellent English communication and team leadership skills.
• Strong judgment, emotional maturity, and the ability to lead in a high-growth, culturally dynamic environment.

Why Consider This Role in Thailand

• A senior leadership position in a strategic global facility.
• Opportunity to lead and build long-term engineering capabilities
• A supportive, international work environment in Thailand.
• Exposure to a high-quality lifestyle in a safe, affordable location.
• Full relocation package including:
• Visa and work permit support
• Company-provided housing and transportation
• Premium family medical insurance
• Annual round-trip flights to home country (2 tickets per year)
• International school tuition coverage for children aged 3+
• Attractive compensation and benefits package.

About Chonburi, Thailand

Located between Bangkok and Pattaya, Chonburi is one of Thailand’s premier industrial regions, offering a family-friendly and expat-welcoming environment. Enjoy a balance of relaxed coastal living with easy access to the bustling capital. This region features:

• Excellent international schools
• Modern healthcare facilities
• Strong expat and professional community
• Affordable lifestyle and high living standards