Quality Director (Medical Device)
Location Hong Kong
Consultant Zoie Lin
Date posted 03 March 2017
The global medical device manufacturer is looking for a Operation Quality Director to join their HK office.
- Direct all Quality Assurance and Control activities within the AP plants and with key suppliers.
- Ensure alignment of plant QS to Local/Regional Regulations, EQMS and GQMS.
- Ensure plant quality system and product quality are in compliance with Regulatory, CE, ISO and Supplier requirements.
- Direct quality improvement activities such as CRM and CAPAs to established KPIs.
- The position includes frequently travel within the Asia Pacific plants/region.
- The work environment is a multicultural/multilingual one in a highly matrix organisation.
- More than 50% travel may be required.
- BS or BEng with focus on Science or Engineering.
- Minimum of 10 years’ progressive experience in Medical Device and/or Pharmaceutical industry.
- Advanced knowledge of applicable quality management standards, e.g. ISO13485, FDA 21CFRs, and medical/medicinal devices regulations.
- Experience in Project Management and electronic systems such as TrackWise, PTC, Microsoft platform, etc.
About the organization:
This is a well-known medical device manufacturers with over 100,000 employees all over the world.