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

BSI; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A global standards organization is seeking a Technical Specialist and Scheme Manager (Microbiology) to conduct audits and ensure compliance in medical devices. The ideal candidate will have over four years’ experience in microbiology or sterilization engineering, particularly in sterilization methods like Gamma and EO. Strong communication abilities are essential, especially if applying for roles based in Japan or South Korea, where native language skills are required. This role significantly impacts patient safety and the market introduction of new products.

Qualifications

• Minimum four years’ experience working as a microbiologist or sterilization engineer.
• Familiar with Gamma and EO sterilization methods.
• Thorough knowledge of ISO 13485 quality standard.

Responsibilities

• Plan, report, and perform audits of clients’ management systems for compliance.
• Conduct comprehensive medical device reviews including sterilization validation.
• Make recommendations for certification based on safety and effectivity.

Skills

Microbiology

Sterilization Engineering

Quality Management

Regulatory Compliance

Education

Bachelor’s degree in Microbiology or related field

Job description

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

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

Location: Japan/South Korea (remote)

This role required to work in Japan or South Korea

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 the areas of 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 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.

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. Please carefully review the qualifications listed below and apply if you meet the criteria.

Education/Qualifications:

• A minimum of four (4) years’ experience working as a microbiologist and/or sterilization engineer for asterile 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.

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 organizations 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, organizations and governments. Utilizing 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 organizations 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.