Quality Assurance (QA) Specialist, East Asia

Work Flexibility: Hybrid

About the job:

To support the implementation and maintenance of the East Asia Quality Management System (QMS) and ensure compliance with Stryker corporate requirements, local regulatory requirements, and applicable quality standards.

What you will be doing:

- Support the implementation and maintenance of the QMS and continuous improvement activities in East Asia.
- Management of Product Complaints, Commercial Holds, Field Safety Corrective Actions (FSCAs)/Product Field Actions (PFAs), and Adverse Event reporting activities with the local teams and manufacturing divisions, to ensure timely execution and closure in accordance with internal and regulatory requirements.
- Support regulatory reporting activities by providing quality-related information and documentation required for submissions to local regulatory authorities.
- Support document control activities, including document change management and training management, in accordance with established procedures.
- Monitor and maintain quality key performance indicators (KPIs), and support periodic reporting activities, where required.
- Support internal and external audits preparation, where required.
- Assist in maintaining compliance with QMS requirements and support implementation of quality process improvements.
- Maintain awareness of applicable quality and regulatory requirements and support implementation of required actions.
- Perform assigned quality activities, as need and opportunities arise.
- Collaborate with cross-functional teams and East Asia QA team to support effective QMS implementation.

Who are we looking for:

- Minimum bachelor's degree in Pharmacy, Biomedical Sciences or a related discipline.
- Experience in the medical device, healthcare, or pharmaceutical industry is preferred.
- Knowledge of quality management systems and applicable regulations or standards (e.g., ISO 13485, GDPMDS, GDPMD) is preferred.
- Strong attention to detail and quality mindset.
- Good communication skills.
- Ability to work independently and manage multiple priorities.
- Strong organizational skills.
- Collaborative and proactive.
- Ability to work effectively across functions and cultures.
- Collaborate effectively with cross-functional teams to support quality objectives.

Travel Percentage: None