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

BSI; South Africa; Remote; ZAR 1 200 000 - 1 715 000; Full time

Job summary

A leading business improvement and standards company is seeking a Technical Specialist and Scheme Manager (Microbiology) to ensure compliance with sterilization and microbiological testing standards. The role requires a minimum of four years of experience and a relevant degree. Candidates in Japan must be native Japanese speakers, while those in South Korea must speak Korean. A commitment to safety and quality in medical devices is essential.

Qualifications

• Minimum of four years' experience as a microbiologist or sterilization engineer for a sterile medical device manufacturer.
• Thorough knowledge of ISO 13485 quality standard and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR).
• Native Japanese required for roles in Japan; Native Korean for roles in South Korea.

Responsibilities

• Responsible for planning, reporting and performing audits of clients’ management systems.
• Conduct comprehensive in-depth medical device reviews including sterilization validation.
• Make recommendations on issuing certificates based on objective evidence.

Skills

Microbiology

Sterilization engineering

Quality management

Communication

Education

Bachelor’s degree or higher in Microbiology, Biology or related scientific degree

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.