Technical Microbiologist and Quality Assurance Specialist

2 weeks ago


Chaoyang Qu, China BSI Full time

Become part of our team at BSI as a Technical Microbiologist and Quality Assurance Specialist.

Job Title: Technical Specialist and Scheme Manager (Microbiology)

Location: Remote

We are seeking a skilled Microbiologist to join our team and help clients navigate the areas of compliance within the areas of sterilization, packaging, and microbiological testing outlined under ISO 13485.

Responsibilities:

· Responsible for planning, reporting, and performing audits of clients' management systems ensuring compliance with regulatory and voluntary requirements.

· Conduct comprehensive in-depth medical device reviews (including sterilization validation).

· Make recommendations whether to issue a certificate, based on objective evidence that the device is safe and effective.

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.

Education/Qualifications:

· Bachelor's degree (or higher) in Microbiology, Biology, or related scientific degree.

· Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR).

· Quality management experience including significant participation in third-party quality audits.

· Native Mandarin speaking required for the role in China.

· Native Japanese speaking required for the role in Japan.

Excellence Behaviours: Client-centric, Agile, Collaborative.

BSI is committed to ensuring a safe and healthy work environment for all employees.


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