Medical Device Quality Assurance Specialist
1 week ago
We are seeking a skilled professional to fill the role of Quality System Specialist. This is a 1-year contract position that requires strong experience in medical devices commercial QA.
Responsibilities:- Warehouse Quality Management: Ensure quality control processes are implemented and maintained for all products.
- Product Inspection Process and Product Release Process: Develop and maintain procedures for inspecting and releasing products, including imported finished goods and returned products.
- Country Specific Labeling Process: Maintain compliance with country-specific labeling regulations.
- Quality Hold Implementation and Tracking: Implement and track quality holds (global and local) in 3PL systems.
- Quality Agreements: Drive improvement for 3PL quality management systems and implement quality agreements.
- Rework Activities: Drive and execute rework activities to ensure product quality.
- Internal Complaints: Initiate and track internal complaints resulting from labeling and regulatory non-compliance.
- First Article Inspection: Perform first article inspections for products distributed in Asia Pacific and Greater China regions.
- Bachelor's degree in a related field.
- Minimum 3 years of previous experience in quality and/or manufacturing environments in the medical device industry.
- Good knowledge of medical or pharmaceutical regulations.
- Understanding of medical devices regulations (e.g., ISO13485).
- Attention to detail and ability to interact professionally with all organizational levels.
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