Sterilization validation expert / R&D Microbiology(remote in Japan)

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Job title : Technical Specialist and Scheme Manager (Microbiology) - relocation acceptable.

Location : Japan / South Korea (remote). If you want to move back to Japan / South Korea, that would also be fine with us.

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 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.

Technical Specialist 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 recommendation whether to issue a certificate, based on objective evidence that the device is safe and effective.

The Technical Specialist – Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients.

Education / Qualifications

About Us BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organisations and society, building trust and enhancing lives. Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organisations and governments. Utilising its extensive expertise in key industry sectors – including automotive, aerospace, built environment, food and retail, and healthcare – BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client‑Centricity, Agility, and Collaboration, BSI provides organisations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between – to accelerate progress towards a better society and a sustainable world. BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Seniority level : Mid‑Senior level

Employment type : Full‑time

Job function : Quality Assurance

Industries : Professional Services

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