BSI is a leading provider of standards-based solutions in the fields of health, infrastructure, industry, and performance management.

We are seeking a Senior Microbiologist to join our team in China or Japan. This role requires strong technical expertise in microbiology, sterilization, and quality assurance. As a Senior Microbiologist, you will be responsible for planning and conducting audits of clients' management systems to ensure compliance with regulatory requirements. You will also conduct comprehensive reviews of medical devices, including sterilization validation, and make recommendations on certification.

The ideal candidate will have a minimum of four years' experience working as a microbiologist and/or sterilization engineer for a sterile medical device manufacturer. A bachelor's degree in microbiology, biology, or a related scientific field is required, as well as thorough knowledge of ISO 13485 and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR). Quality management experience and participation in third-party quality audits are essential. Native Mandarin speaking is required for roles based in China, while native Japanese speaking is required for roles based in Japan.

In this role, you will apply your expertise to impact patient safety and help determine which new products go to market. You will work closely with clients to understand their needs and provide guidance on compliance with regulatory requirements. The salary for this role is approximately $120,000 per year, depending on location and experience.

At BSI, we value client-centricity, agility, and collaboration. These behaviors represent how we do things at BSI and help us ensure that BSI is a great place to work and a highly successful business.