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.

Job Summary

We are seeking a highly experienced and strategic Supply Chain Director to lead and optimize our entire supply chain operations in Thailand. This permanent position offers a unique opportunity to shape the future of our supply chain, drive efficiency, foster innovation, and ensure seamless delivery of products to our customers. The successful candidate will be a visionary leader with a proven track record in supply chain management within a dynamic, fast-paced environment.

Key Responsibilities

• Develop and implement a comprehensive supply chain strategy aligned with company goals and market demands.
• Oversee all aspects of the supply chain, including procurement, logistics, warehousing, inventory management, and distribution.
• Lead and mentor a team of supply chain professionals, fostering a culture of continuous improvement and high performance.
• Optimize inventory levels across the network to minimize costs while ensuring product availability.
• Negotiate and manage relationships with suppliers, third-party logistics providers, and other external partners to ensure cost-effectiveness and service excellence.
• Implement and manage supply chain analytics to identify trends, opportunities, and areas for improvement.
• Ensure compliance with all relevant local and international regulations, quality standards, and company policies.
• Drive initiatives to improve supply chain resilience, sustainability, and digital transformation.
• Collaborate cross-functionally with sales, marketing, production, and finance teams to ensure integrated business planning.

Required Qualifications

• Bachelor's degree in Supply Chain Management, Logistics, Business Administration, Engineering, or a related field.
• Master's degree in a relevant discipline (e.g., MBA, Supply Chain Management) is highly preferred.
• Professional certification such as CSCP (Certified Supply Chain Professional), CPIM (Certified in Production and Inventory Management), or CLTD (Certified in Logistics, Transportation and Distribution) is a significant advantage.

Required Skills

• Exceptional leadership and team management abilities.
• Strong analytical and problem-solving skills with a data-driven approach.
• Proven ability to develop and execute complex supply chain strategies.
• Excellent negotiation and vendor management skills.
• Proficiency in supply chain planning and execution systems (e.g., ERP, WMS, TMS).
• Advanced communication and interpersonal skills, capable of influencing stakeholders at all levels.
• Strong understanding of international trade, customs regulations, and logistics.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.

Preferred Experience

• Minimum of 10-15 years of progressive experience in supply chain management, with at least 5 years in a senior leadership role (e.g., Supply Chain Director, Head of Supply Chain).
• Extensive experience working within the Thai market and understanding of local supply chain dynamics.
• Demonstrated experience in implementing supply chain technology solutions and digital transformation initiatives.
• Proven track record of achieving significant cost savings and efficiency improvements in supply chain operations.
• Experience in a multinational company environment.

Additional Requirements

• Fluency in English (written and spoken) is essential.
• Proficiency in Thai (written and spoken) is highly desirable.
• Willingness to travel domestically and internationally as required.
• Ability to adapt to a diverse cultural and business environment.