A new and exciting role has opened with a global medical devices MNC that specializes in endoscopy and various consumables. They are now looking for an APAC Quality Assurance Manager.
Reporting into the VP of Quality, you will be responsible for quality-related issues within the APAC region:
- Manage complaint handling process for product complaints reported and ensure quality-related issues are resolved. Assume role as a Subject Matter Expert in CAPA management, tracking and reviewing of open CAPAs and ensure timely closure.
- Manage distributors and suppliers where necessary. Lead internal audits and supports external audits and inspections according to ISO 13485
- Work closely with cross functional teams to ensure QMS compliance to company's quality systems requirements and international medical devices manufacturing standards
- Consolidate quality data, analyzing trends and implementing continual improvements to the company's QMS and reporting systems
To qualify for this role you should have:
- Degree in Life Sciences or Bioengineering with at least 10 years of experience in highly-regulated industry, preferably in medical devices or IVD industries.
- Strong knowledge in ISO 13485. Able to lead internal audits will be a plus
- Prior work experience with distributors across the APAC regions and suppliers will be advantageous
- Fluent in both English and Mandarin (to liaise with sister companies). Knowledge in Japanese and Korean language will be value-added.
- Ability to travel frequently
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).
