Technical Microbiologist and Quality Assurance Specialist
2 weeks ago
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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