Iso13485 Medical Device Auditor (microbiology微生物背景优先)-remote
BSI Group
Taipei, Taiwan
Iso 13485 quality management systems assessment
Eu medical device regulation knowledge
Mdsap scheme auditing
You will assess ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites and present comprehensive reports to clients
Job Summary
You will assess ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites and present comprehensive reports to clients.
BSI is a global business standards company dedicated to creating positive change for people and the planet while supporting timely market access for medical device products worldwide.
The role includes extensive training such as ISO13485 Lead Auditor course, MDSAP, and MDR, with opportunities for occasional international travel to the USA and Europe.
Matching Summary
You will assess ISO 13485 quality management systems, EU medical device regulations, and MDSAP scheme on customer sites and present comprehensive reports to clients.
Skills & Requirements
Must-have
ISO 13485 quality management systems assessment
EU medical device regulation knowledge
MDSAP scheme auditing
Microbiology background in sterile product manufacture
Extensive business travel across Taiwan
Report writing and client presentation
Nice-to-have
Good public speaking skills
Business development skills
Team player with relationship building
Self motivated and flexible
Excellent time management and planning
Key Requirements
Bachelor degree or above in medical device related major
Minimum 5 years quality and technology management experience
Hands-on microbiologist experience in sterile product manufacture