Our strategic partner is a leading multinational manufacturer of medicals devices, renowned for producing tight-tolerance, precision medical components through cutting-edge extrusion and molding processes. Currently, our strategic partner is expanding its business operations in Vietnam and is seeking to fill key positions for its activities in this new market.
Location: Bac Ninh, Vietnam
Job Responsibilities
- Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485:2016 requirements, applicable international standard/regulation requirements, and customer requirements.
- Responsible for QMS-related training sessions at the Vietnam facility and responsible for implementing and maintaining the Quality Management System (QMS) ensuring compliance with company and regulatory standards.
- Identify the gap in the QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements. Lead the training on procedures and practices to QMS requirements.
- Lead the internal audit, customer audit, management review, follow-up on audit non-conformance activities till closure.
- Responsible for major customer projects and quality deliveries, handling product quality issues, and responding to major customer complaints and quality improvement.
- Manage and verify CAPA, NCR, SCAR handling, root cause analysis, and lead the cross-functional team to implement corrective and preventive actions.
- Responsible for reviewing risk management, validation and verification activities etc. documents.
- Provide the necessary training, such as QMS, supplier management, design control, MSA, G R&G, 8D etc.
- Authorize the release of major customer products.
- Responsible for monthly quality objective and KPI review to identify trends and areas for improvement.
- Any other duties as assigned from time to time.
Job Requirements
- Bachelor or above
- Proficient in two languages: English, Chinese.
- Minimum of 5 years’ experience in medical device quality management, with at least 3 years in a leadership role.
- Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, Cleanroom, and related medical device standards and regulations.
- Good communication and teamwork, good leadership, taking charge, open-minded.
If you possess the required skills and experience and are ready to significantly contribute to the dynamic team, we warmly welcome your application at vy.cao@peoplewise.vn or application@peoplewise.vn.
About PeopleWise Vietnam:
PeopleWise Vietnam was founded with the mission of positively impacting our community by improving the quality of the labor force, addressing workforce dynamics, and enhancing its effectiveness. During our initial phase, we provided solutions and human resources consulting services to our partners worldwide, including workforce advisory, organizational diagnosis, career transition, training services, talent management, and staffing solutions that align with each organization’s values and vision, driving business success.
Visit us at our website: https://peoplewise.vn/
To apply for this job email your details to vy.cao@peoplewise.vn