Medical Device Quality Assurance Manager LSMD_662
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Description
- Lead and maintain the Quality Management System (QMS) to ensure compliance with ISO 13485, TFDA, GDP, and applicable regulatory requirements
- Manage internal and external quality audits, including supplier audits, customer audits, and third-party certification audits
- Oversee CAPA, Deviation, NCR, Change Control, and quality system processes to ensure effective implementation and continuous improvement
- Monitor quality KPIs, analyze quality issues, and drive cross-functional improvement initiatives
- Supervise IQC, IPQC, OQC, and final product release processes to ensure product quality and compliance standards are met
- Handle customer complaints, product investigations, and risk assessments, including root cause analysis and corrective actions
- Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supply Chain teams to support product development and production quality activities
- Maintain and manage quality documentation, including SOPs, DHR, DMR, validation documents, and quality records
- Support post-market quality monitoring and customer quality issue resolution
- Lead, coach, and develop the QA team to strengthen organizational quality capability