QMS manager - Medical Device
Career Growth Opportunities
Leading Manufacturer in Medical Device Industry
About Our Client
Our client is a High-Tech Medical Device manufacturing company.
1. Establish and monitor quality management system documentation activities to ensure the quality or regulatory related activities meet company policy, customers and related regulatory requirements.
2. Organize, implement internal audit. Establish the annual internal audit plan, follow up the implementation status and findings closure when necessary.
3. In charge of External/3rd Party Audit. Communicate with External/3rd Party audit team, organize the preparation internally, escort the external auditor(s) during the audit conduction and follow up the audit closure.
4. Handling the Customer Complaint. Provide supportive data/information to client to support their customer complaint handling. Organize and report internal investigation result to client when necessary.
5. CAPA management. Coordinate, follow up each CAPA's implementation, maintain the CAPA data report, trend analysis, identify the needs of continuously improvement.
6. Participate in the Qualification & Validation activities when necessary to ensure the compliance to all applicable regulations and product standards.
7. Responsible for Quality Management System related training. Plan and implement the training, consistently promote the sense on Quality within entire plant.
8. Coach and develop the QMS Team.
9. Deal with other assignments from superior.
The Successful Applicant
◆ Bachelor degree or above, the science and engineering is preferential.
- Above 3 years relative working experience.
- Be proficient in ISO9001 /ISO13485/QSR820 management system, have practical experience in dealing with
FDA audit is preferential.
- Proficient in English both at written, oral, reading and listening.
- Good communication skills and logical mind.
- Familiar with quality tools (6 sigma, APQP, PPAP, FMEA, SPC, etc.) is preferential.
What's on Offer
Attractive Remuneration Package