Quality Assurance (QA) Specialist, East Asia

Stryker Singapore Private Limited; Singapore; Hybrid; SGD 70,000 - 110,000; Full time

Job summary

Stryker is seeking a Quality Assurance professional to support the East Asia QMS implementation and ongoing compliance with regulatory requirements. The role involves handling product complaints, field actions, adverse event reporting, and coordinating with local manufacturing teams to ensure timely closure and adherence to ISO 13485 and local standards.

The candidate will assist in document control, training management, and KPI monitoring, while ensuring awareness of regulatory changes and

Qualifications

• Requires a Bachelor's degree in Pharmacy, Biomedical Sciences or related field.
• Experience in medical device, healthcare, or pharmaceutical industry preferred.
• Knowledge of quality management systems and regulations (ISO 13485, GDPMDS, GDPMD) preferred.

Responsibilities

• Support the implementation and maintenance of the QMS in East Asia.
• Manage Product Complaints, Holds, FSCAs/PFAs, and Adverse Event reporting with local teams.
• Support regulatory reporting for submissions to local authorities.
• Assist document control activities including change management and training.
• Monitor quality KPIs and assist with periodic reporting.
• Support internal and external audits preparation.

Skills

Quality mindset

Attention to detail

Communication

Independent

Organizational skills

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy or Biomedical Sciences

Job description

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.
• Collaborate effectively with cross-functional teams to support quality objectives.

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.

Travel Percentage: None

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.