Medical Device Quality Assurance Specialist
3 days ago
The ideal candidate will possess a strong background in quality assurance and experience in the medical device industry. We are seeking a dedicated professional to oversee the implementation and maintenance of product inspection processes, ensuring compliance with country-specific labeling regulations.
Key Responsibilities:- Product Inspection Process Management: Implement and maintain Product Inspection Process, including Imported Finished Goods, and Returned Products
- Compliance Oversight: Maintain compliance of country specific labeling process
- Quality Hold Management: Implement and track Quality Hold (Global & local) in 3PL
- Quality Agreements: Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements
- Rework Activities: Drive and execute rework activities
- Internal Complaints: Initiate and track internal complaints resulting from labeling and other regulatory non-compliance
- First Article Inspection: Perform first article inspection (FAI) for product distributed in Asia Pacific & greater China region
- Warehouse Procedures: Ensure implementation of company's procedure/work instruction in warehouse
- Supplier Management: Manage and follow up SCARs
- Quality Engineering: Act as quality engineer for Asia Pacific labeling and other quality documentation
- Supply Chain Management: Maintain existing supplier and support in new supplier qualification
- Supplier Training: Provide Quality Training to suppliers
- Supplier Control Process: Implement Supplier Control Process
- Oversight and Compliance: Oversight and maintain compliance of Product Complaint Handling Process in APAC includes receiving and reporting complaints to CH Center, following up Complaint Investigation, sample return etc.
- Field Corrective Action: Execute Field Corrective Action Process includes operations in JDE system. Act as Local FCA Coordinator for Region
- Quality Reporting: Generate quality system reports and perform trend analysis
- Training Compliance: Maintain training compliance for region
- Audit Participation: Participate on audit teams by responding and gathering data to address audit requests
- NCR, CAPA, PRA Management: Own and manage NCR, CAPA, PRA in region
- Quality Systems Assessment: Assess the impact of quality systems information (e.g., Enterprise Change Requests (ECRs), CAPA) and provide feedback to originators
- Other Duties: Other incidental duties
Experience Required:
- Bachelor's degree in related field
- 3 years of previous experience in quality and/or manufacturing environment in the medical device industry
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