Sr. QA Specialist
Stryker(2 months ago)
About this role
Responsible for executing post-market surveillance (PMS) activities and supporting the quality management system for medical devices to ensure compliance with applicable regulatory and corporate requirements. The role maintains and integrates PMS data into QMS, risk management, and product improvement processes while coordinating with global manufacturers, regulatory authorities, and cross-functional teams. The position also supports KGMP compliance, field actions, and regulatory reporting for the product portfolio.
Required Skills
- Post-Market Surveillance
- Complaint Handling
- Vigilance Reporting
- Field Actions
- Risk Management
- Regulatory Reporting
- QA Systems
- Trend Analysis
- Audits
- Cross-Functional Collaboration
Qualifications
- Bachelor's Degree in Life Sciences or Biomedical Engineering
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