Quality Systems Specialist (Medical Device MNC) - HYN
- Work on compliance activities
- Evaluate procedural compliance such as review and develop procedures and determine appropriate escalation process
- Conduct investigation and analysis of customer complaints
- Highlight the trends to manufacturing for improvements.
- Drive CAPA meeting, work with cross-functional team for solution implementation and effectiveness of the solution and conduct monthly data trend.
- Perform Internal Audit to identify gaps in compliance or nonconformance for the site, ensure audit reports are approved and filed timely, ensure audit findings are closely monitored and closed with objective evidence.
- Work closely with cross-functional team to ensure that QMS processes remain relevant and compliant to applicable internal and external requirements, and provide guidance to the key stakeholders on overall QMS regulations, includes the support of new production transfer and validation activities.
- Bachelor’s degree or equivalent in a related life science/ technical discipline or equivalent preferred.
- Working knowledge of device/drug/biotech manufacturing processes.
- Understanding of GMP and quality system standards
- Min 5 years experience in a manufacturing industry
- Demonstrated proficiency in use of engineering tools - FMEA, SPC or equivalent statistical tools, etc.
- Knowledgeable in writing manufacturing procedures to QMS/GMP requirements.
- Knowledge of ISO13485, FDA 21 CFR Part 820, and/ or the Medical Device
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