Quality Management System (QMS) Engineer: Bac Ninh, Yen Phong expansion industrial park
AP Technologies
Location: Gmap link
Roles & 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.
About AP-TECHNOLOGIES
- AP Technologies is a multinational medical device contract manufacturer (Head office in Singapore) that specializes in tight tolerance, precision medical components using the latest extrusion and molding processes. We utilize our comprehensive quality control system, state-of-the-art facility, and advanced statistical methodologies to maintain the highest quality standards in the industry.
- Vietnamese Company size: 100 – 200 staffs
