
Product Inspection and Compliance Specialist
7 days ago
**Job Summary:**
As a Contract Quality Systems Specialist, you will be responsible for implementing and maintaining product inspection, release, labeling, and rework processes.
You will oversee quality holds, SCARs, and internal complaints, ensuring compliance with company SOPs at 3PL locations.
**Key Responsibilities:- Implement and maintain product inspection, release, labeling, and rework processes.
- Oversee quality holds (local & global), SCARs, and internal complaints.
- Perform First Article Inspections (FAI) for products across Asia Pacific and Greater China.
- Ensure compliance with company SOPs at 3PL locations.
- Maintain and qualify suppliers.
- Provide quality training and ensure supplier control measures are in place.
- 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.
- Own and manage NCRs, CAPAs, and PRA activities.
- Assess ECRs and contribute feedback for continuous improvement.
- Participate in internal/external audits.
- Maintain training records for compliance.
**Requirements:
- Min. Bachelor's degree in related field.
- 3 years of experience in Manufacturing environment in the Medical Device industry will be an advantage.
- Experience with ISO13485.
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