Quality Systems Compliance Expert
2 weeks ago
About the Role:
We seek a meticulous quality assurance specialist to support our operations in Asia Pacific and Greater China. This role is ideal for individuals with a strong understanding of quality systems and regulatory requirements.
Key Responsibilities:
- Develop and maintain product inspection, release, labeling, and rework processes at warehouses across Asia Pacific and Greater China.
- Oversee quality holds (local & global), SCARs, and internal complaints to ensure compliance with regulatory requirements.
- Perform First Article Inspections for products and guarantee compliance with company SOPs at 3PL locations.
- Maintain and qualify suppliers based on their ability to meet quality standards.
- Provide quality training and implement supplier control measures to ensure compliance.
- Manage product complaint handling, field corrective actions, and relevant reporting in APAC.
- Coordinate with central complaint handling and JDE systems for sample tracking and documentation.
- Generate quality reports and trend analysis to identify areas for improvement.
- Own and manage NCRs, CAPAs, and PRA activities to ensure prompt resolution of issues.
- Assess ECRs and contribute feedback for continuous improvement.
- Participate in internal/external audits to ensure compliance with quality standards.
- Maintain training records for compliance purposes.
Requirements:
- Bachelor's Degree in a relevant field such as quality assurance or engineering.
- Minimum 3 years of experience in quality or manufacturing, preferably in the medical device sector.
- Strong knowledge of ISO 13485, medical/pharma documentation, and quality systems.
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