Assistant Quality Manager: Bac Ninh, Yen Phong expansion industrial park
AP Technologies
Location: Gmap link
Roles & 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.
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
