Supports the East Asia Quality Management System, including product complaints, commercial holds, field safety actions, adverse event reporting, regulatory documentation, document control, training management, KPI reporting, audits, and quality process improvements. Collaborates with cross-functional teams to maintain compliance with corporate, regulatory, and applicable quality standards.
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.
Similar Jobs
Healthtech
Supports the East Asia Quality Management System, complaint and corrective action processes, adverse event reporting, regulatory submissions, document control, training, KPI monitoring, audits, and quality improvement activities. Collaborates with local, manufacturing, regulatory, and cross-functional teams to maintain compliance with corporate, local, and applicable quality requirements.
Top Skills:
GdpmdGdpmdsIso 13485Quality Management Systems (Qms)
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Leads AI transformation, governance, quality oversight, risk management, and responsible adoption across Pfizer Global Supply and QSEO. Establishes GxP-compliant AI lifecycle practices, inspection-readiness frameworks, governance forums, portfolio monitoring, inventory management, metrics, and reporting. Advises senior leaders on AI regulations, deployment risks, investment priorities, and compliance while leading cross-functional initiatives and influencing stakeholders across Quality, Digital, Operations, and R&D.
Top Skills:
Ai GovernanceAiqasAirifArtificial IntelligenceComputerized SystemsGxpImexLeanMachine LearningSix Sigma
.jpeg)
Artificial Intelligence • Hardware • Information Technology • Machine Learning
Operate and engineer database systems supporting manufacturing and engineering. Responsibilities include installation, upgrades, patching, access management, backups, performance tuning, monitoring, incident resolution, disaster recovery, capacity planning, reporting, automation, and business continuity. The role provides on-call support, collaborates with customers on database requirements, improves operational reliability, and evaluates emerging database technologies and AI-assisted tools.
Top Skills:
Ai-Assisted ToolsDatabase MonitoringDatabase SystemsDisaster RecoveryFailover TestingJavaLinuxMicrosoft Sql ServerOracle DatabasePowershellPythonSQLWindows
What you need to know about the Singapore Tech Scene
The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.
