Quality Assurance Manager

Position Summary

Our client, a global manufacturer within the healthcare and medical technology sector, is seeking an experienced Quality Assurance Manager to lead the Quality function for its manufacturing operations in Thailand.

This role will be responsible for establishing, implementing, and continuously improving the site's Quality Management System (QMS), ensuring compliance with applicable regulatory standards, customer requirements, and international quality systems. The successful candidate will also play a key role in supporting new product introductions, product transfers, validation activities, supplier quality, and building a high-performing quality organization.

Key Responsibilities

• Lead the establishment, implementation, and continuous improvement of the site's Quality Management System (QMS).
• Build, develop, and lead the Quality team, including recruitment, coaching, performance management, and capability development.
• Serve as the site's Quality Management Representative, ensuring compliance with applicable regulatory and quality standards.
• Oversee Quality Control operations to ensure products consistently meet customer specifications and regulatory requirements.
• Support New Product Introduction (NPI), product transfer, localization, and engineering change projects from a quality perspective.
• Develop and manage supplier quality programs, including supplier qualification, performance monitoring, and continuous improvement initiatives.
• Lead customer quality communications, including complaint investigations, deviation management, quality performance reviews, and corrective action activities.
• Manage calibration programs and ensure ongoing equipment compliance.
• Plan, coordinate, and lead customer, certification, and regulatory audits while ensuring timely closure of audit findings.
• Oversee validation activities, including IQ, OQ, PQ, process validation, equipment qualification, and validation lifecycle management.
• Drive continuous improvement initiatives across manufacturing and quality operations using structured problem-solving methodologies.
• Promote a strong Quality Culture by providing coaching, training, and cross-functional collaboration throughout the organization.
• Support additional business and operational initiatives as required.

Qualifications

• Bachelor's Degree or higher in Engineering, Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
• Minimum 6 years of Quality Assurance experience within the medical device, pharmaceutical, or regulated healthcare manufacturing industry.
• Proven experience establishing, maintaining, and improving Quality Management Systems within a regulated manufacturing environment.
• Strong knowledge of ISO 13485, GMP, regulatory compliance, quality systems, validation, CAPA, supplier quality, and audit management.
• Experience supporting New Product Introduction (NPI), product transfers, process validation, and manufacturing quality.
• Demonstrated leadership experience in building, developing, and managing Quality teams.
• Strong communication, stakeholder management, and problem-solving skills.
• High level of integrity with the ability to communicate effectively with senior management and regulatory bodies.
• Fluent in both Thai and English.