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
- Develop, implement and maintain the Quality Management System (QMS) in compliance with ISO 13485:2016 requirements, the applicable international standard, regulatory 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.
- Continuously improve QMS for effective implementation consistent with product and process requirements.
- Responsible for the maintenance of QMS documents, and document control work that includes document training, distribution, obsolete, archive, update list, etc.
- Plan, conduct Lead, and organize the internal, external, and customer audits. Manage the coordination and preparation with relevant departments before and after the audit.
- Lead and follow-up on audit findings, investigation of quality issues, develop the action plan, and verity effectiveness till closure.
- Regularly supervise and inspect cross-department QMS documents, identify potential problems in time, communicate and coordinate with relevant departments, solve potential or known problem points, take adequate prevention, and actively participate in the improvement of the company’s processes and procedures.
- Participate in quality management reviews and assist superiors in preparing, implementing, and tracking management reviews’ results.
- Organize and deliver training programs. Promote quality awareness to achieve the company’s quality policy/objectives
- Responsible for cleanroom environment management and monitoring, as well as monthly reports and analysis.
- Support on monthly quality objective and KPI review. Prepare quality performance metrics and KPIs reports monthly.
- Any other duties as assigned from time to time.
Job Requirements
- Diploma or above.
- Proficient in two languages: English, Chinese.
- Minimum of 3 years’ experience in medical device QA and/or RA in manufacturing environment.
- Qualified ISO 13485:2016 internal auditor. Be familiar with ISO 14971:2019, Cleanroom, and related medical device standards and regulations.
- Effective communication and interpersonal skills to collaborate with multi-functional teams.
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