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Key Responsibilities
Develop, implement, and maintain the Quality Management System (QMS) in full compliance with ISO 13485:2016 and all applicable international, regulatory, and customer requirements.
Lead QMS-related training sessions at the Vietnam facility; ensure ongoing compliance with company and regulatory standards through effective system implementation and maintenance.
Continuously review and improve the QMS to ensure its effective application remains consistent with product and process requirements.
Maintain QMS documentation and oversee document control activities, including training, distribution, archiving, obsolescence management, and version tracking.
Plan, lead, and organise internal, external, and customer audits; manage pre- and post-audit coordination across relevant departments.
Lead follow-up on audit findings and quality issues; develop and implement corrective action plans and verify effectiveness through to closure.
Conduct regular cross-departmental QMS inspections to identify potential issues proactively; communicate and coordinate with relevant teams to resolve known and emerging risks.
Participate in management reviews; assist in the preparation, execution, and tracking of management review outcomes.
Organise and deliver training programmes; promote a culture of quality awareness in line with the company’s quality policy and objectives.
Manage and monitor cleanroom environmental conditions; prepare monthly reports and trend analysis.
Support monthly quality objective and KPI reviews; prepare quality performance metrics and KPI reports on a monthly basis.
Perform any other duties as assigned.
Requirements
Education — Diploma or above in a relevant discipline
Experience — Minimum 3 years of experience in quality assurance and/or regulatory affairs within a medical device manufacturing environment
Technical Knowledge — Qualified ISO 13485:2016 internal auditor; familiarity with ISO 14971:2019, cleanroom standards, and relevant medical device regulations
Skills — Effective communication and interpersonal skills; ability to collaborate productively with multi-functional teams across different levels of the organisation
Language — Proficient in English, Chinese (Mandarin), and Vietnamese