BSI · 2 days ago
Sterilization validation expert/R&D Microbiology(remote in Japan)
United States
Full-time
Remote
Mid, Senior Level
4+ years expBSI is a business improvement and standards company that aims to create positive change for people and the planet. They are seeking a Technical Specialist and Scheme Manager in Microbiology to help clients navigate compliance in sterilization and microbiological testing while ensuring patient safety and product effectiveness.
Business DevelopmentCollaborative ConsumptionRecruiting
Hiring Manager
Crystal T. Brown
Responsibilities
Responsible for planning, reporting and performing of audits of clients’ management systems ensuring compliance with regulatory and voluntary requirements
Conduct comprehensive in-depth medical device reviews (including sterilization validation)
Make recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective
Qualification
Required
A minimum of four (4) years' experience working as a microbiologist and/or sterilization engineer for a sterile medical device manufacturer
Bachelor's degree (or higher) in Microbiology, Biology or related scientific degree
Familiar with Gamma and EO sterilization
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
If you apply the role in Japan, then Native Japanese speaking required
If you apply the role in South Korea then Native Korean speaking required
Company
BSI
BSI Group, also known in its home market as the British Standards Institution, is a multinational business services
1001-5000 employees
H1B Sponsorship
BSI has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (1)
2023 (3)
2022 (6)
2021 (3)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
B
Beverley Webb
Lead Programme Manager, Defence and Security
Egor Malychev
Sales Director DACH
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