Quality Assurance (QA) Specialist, East Asia

About the role

Stryker is hiring a Quality Assurance (QA) Specialist for its East Asia region, based in Singapore. The role supports the implementation and maintenance of the East Asia Quality Management System (QMS) and ensures compliance with Stryker corporate requirements, local regulatory requirements and applicable quality standards. The position is hybrid.

Key responsibilities

• Support the implementation and maintenance of the QMS and continuous improvement activities in East Asia.
• Manage product complaints, commercial holds, field safety corrective actions (FSCAs)/product field actions (PFAs) and adverse event reporting with local teams and manufacturing divisions, ensuring timely execution and closure.
• Support regulatory reporting by providing quality-related information and documentation for submissions to local regulatory authorities.
• Support document control, including document change management and training management, in line with established procedures.
• Monitor and maintain quality KPIs and support periodic reporting where required.
• Prepare for internal and external audits where required, and assist in maintaining QMS compliance and implementing quality process improvements.
• Stay aware of applicable quality and regulatory requirements and support required actions.
• Collaborate with cross-functional teams and the East Asia QA team to support effective QMS implementation.

Required profile

• Minimum bachelor's degree in Pharmacy, Biomedical Sciences or a related discipline.
• Experience in the medical device, healthcare or pharmaceutical industry is preferred.
• Strong attention to detail, good communication skills, and ability to work independently and manage multiple priorities.
• Strong organizational skills, collaborative and proactive, able to work across functions and cultures.

Required skills

• Knowledge of quality management systems and applicable regulations or standards (e.g. ISO 13485, GDPMDS, GDPMD) is preferred.