PR/095857 | QMS Engineer - Medical Device

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