月薪60000~80000元 台中市潭子區 5年工作經驗 今天剛更新
1. Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485, TFDA QMS/GMP, and applicable medical device regulations.
2. Plan and conduct internal audits, management reviews, and coordinate external audits.
3. Manage CAPA, nonconforming products, deviations, and change control activities.
Lead investigations and root cause analysis for customer complaints and quality issues.
4. Support medical device adverse event reporting and regulatory compliance activities.
5. Conduct supplier audits, supplier evaluations, and SCAR follow-up.
6. Supervise daily QA/QC operations and provide technical guidance to team members.
7. Analyze quality metrics and drive continuous improvement initiatives.
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