- Global medical devices company with presence in more than 100 countries
- Fast paced work culture with loads of opportunities to learn and grow
- Vibrant and motivated team
A European medical devices MNC is looking for a resilient, highly energetic and adaptable QMS engineer. Reporting into the Team Lead of Quality, you will be responsible to implement and maintain QMS, documentation control, change management and training.
Responsibilities
- Ensure QMS compliance to company's quality systems requirements and international medical devices manufacturing standards.
- Maintain proper documentation via usage of documentation control system
- Manage non-conformance issues duly. Coordinate and facilitate quality review meetings
- Take charge of change management, working closely with all stakeholders to ensure all changes are properly captured, reviewed and documented.
- Involved in planning and conducting of internal audits and to support external audits
- Support QMS improvement initiatives whenever required
Requirements
- Degree in Biomedical/Mechanical Engineering or equivalent with at least 3 years of experience in medical devices manufacturing
- Good knowledge of regulations such as ISO 13485, FDA 21 CFR part 820, ISO 14971, MDD, local regulations, etc.
- Preferably holds certification as ISO 13485 auditor with experience in supplier audits
- Strong communication skills are required as you are liaising with both internal and external stakeholders
Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).
