Medical Device Quality Assurance Specialist
5 days ago
Job Title: Medical Device Quality Assurance Specialist
We are seeking a seasoned Quality Assurance Specialist to join our team in ensuring the highest standards of quality for medical devices.
Roles & Responsibilities:
- Product Inspection and Release Process: Implement and maintain processes for product inspection and release, including imported finished goods and returned products.
- Compliance: Maintain country-specific labeling compliance.
- Quality Hold Management: Track and implement quality holds in 3PL warehouses.
- Quality Agreements: Drive improvement for 3PL quality management systems and maintain quality agreements.
- Rework Activities: Execute rework activities and track their progress.
- Internal Complaints: Initiate and track internal complaints resulting from labeling and regulatory non-compliance.
- First Article Inspection (FAI): Perform FAI for products distributed in Asia Pacific and greater China regions.
- Procedure Implementation: Ensure implementation of company procedures and work instructions in warehouses.
- SCAR Management: Manage and follow up on SCARS.
- Quality Engineer: Act as a quality engineer for Asia Pacific labeling and other quality documentation.
- Supplier Management: Maintain existing supplier relationships and support new supplier qualification.
- Quality Training: Provide quality training to suppliers.
- Supplier Control Process: Implement supplier control processes.
Post Market Quality Assurance:
- Product Complaint Handling: Maintain compliance of product complaint handling processes in APAC, including receiving and reporting complaints to CH centers, following up on investigations, and sample returns.
- Field Corrective Action (FCA) Process: Execute FCA processes, including operations in JDE systems. Coordinate local FCAs for the region.
- Quality System Reports: Generate quality system reports and perform trend analysis.
- Training Compliance: Maintain training compliance for the region.
- Audit Participation: Participate in audit teams by responding to and gathering data to address audit requests.
- NCR, CAPA, PRA Management: Own and manage NCRs, CAPAs, and PRAs in the region.
- Quality Systems Impact Assessment: Assess the impact of quality systems information, such as ECRs and CAPAs, and provide feedback to originators.
Required Skills and Qualifications:
- Bachelor's Degree: Bachelor's degree in a related field.
- Quality Experience: 3 years of previous experience in quality and/or manufacturing environments in the medical device industry.
We Offer:
- CAPA Expertise: Strong understanding of CAPA processes and principles.
- 3PL Experience: Experience working with 3PL warehouses and logistics providers.
- Quality Management: Proven ability to manage quality systems and processes.
- Quality Assurance: Strong knowledge of quality assurance principles and practices.
- Investigation: Ability to conduct thorough investigations and root cause analyses.
- Trend Analysis: Skill in performing trend analysis and identifying areas for improvement.
- Manufacturing: Understanding of manufacturing processes and quality control measures.
- Audit: Experience participating in audits and providing quality data to auditors.
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