Highly Skilled Quality Management Professional Wanted
2 weeks ago
Our company seeks a highly skilled Quality System Specialist to join our team. This individual will be responsible for implementing and maintaining quality management systems, ensuring compliance with regulatory requirements, and driving process improvements.
Key Responsibilities:- Develop and implement product inspection processes, including Imported Finished Goods and Returned Products.
- Maintain country-specific labeling compliance.
- Track Quality Holds in 3PL warehouses.
- Enhance the 3PL Quality Management System.
- Drive rework activities and initiate internal complaints.
- Perform first article inspections for products distributed in Asia Pacific and greater China regions.
- Implement company procedures and work instructions in warehouses.
- Manage and follow up on SCARs (Supplier Corrective Actions Requests).
- Maintain existing supplier relationships and support new supplier qualification.
- Provide quality training to suppliers.
- Establish Supplier Control Processes.
- Oversight compliance of Product Complaint Handling Process in APAC, including receiving and reporting complaints.
- Execute Field Corrective Action Processes using JDE systems.
- Generate quality system reports and perform trend analysis.
- Maintain training compliance for the region.
- Participate in audit teams by responding to audit requests.
- Bachelor's degree in a related field.
- Three years of experience in quality and/or manufacturing environments within the medical device industry.
- Familiarity with medical or pharmaceutical regulations.
- Knowledge of medical devices regulations, such as ISO13485.
- Attention to detail.
- Excellent communication skills.
- Able to manage competing priorities in fast-paced environments.
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