Sterilization validation expert​/R&D Microbiology; remote in Japan

Technical Specialist and Scheme Manager (Microbiology) – relocation acceptable

Job title: Technical Specialist and Scheme Manager (Microbiology)

Location: Japan / South Korea (remote)

We exist to create positive change for people and the planet. Join us and make a difference too!

Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within sterilization, packaging and microbiological testing outlined under ISO 13485. In this role you will have the opportunity to apply your sterile medical device experience to impact patient safety and help determine which new products go to market.

• 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.

• 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, native Japanese speaking required.
• If you apply the role in South Korea, native Korean speaking required.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

• Mid‑Senior level

• Full‑time

• Quality Assurance