Quality Assurance & Control (Manufacturing, Transport & Logistics)
Full time
1. Manage and oversee the organization's Quality, QA Operation, Inspection, calibration, documentation, certification, etc.
2. Execute, review, and improve the current quality plan to achieve product quality standards, including investigating non-conformities and ensuring corrective & preventive actions are carried out effectively.
3. Attend to customer complaints regarding product quality, perform diagnosis of problems encountered, and resolve them within the given time frame.
4. Attend external audits by customers and Certification Bodies / Notification Bodies.
5. Perform supplier audits as per planned schedule and participate in qualification audits for new suppliers.
6. Maintain and improve the quality management system to ensure compliance with FDA quality system regulations, ISO 13485 requirements, Medical Device Regulations, and all other worldwide medical device quality regulations.
Requirements:
Candidate must possess at least a Degree in Science, Chemistry, Chemical Engineering, Quality Management, or equivalent.
Experience in handling customer feedback or complaints.
Proficient knowledge in ISO 9001, ISO 13485, MDR, PPE Regulation & GMP requirements preferable.
Experience in internal and external audits.
Applicants from a manufacturing environment are an advantage.
Strong interpersonal skills to develop good working relationships at various levels and resolve complaints.
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