CE Technical Specialist /R&D - Microbiology의료기기 살균기술 전문가

BSI; Bloemfontein; Remote; ZAR 1,215,000 - 1,563,000; Full time

Job summary

A leading business improvement company is seeking a Technical Specialist and Scheme Manager in Microbiology. This remote role requires expertise in microbiology and sterilization processes in accordance with ISO 13485 standards. The ideal candidate will have significant experience in audits and quality management. Join us to impact patient safety and compliance in medical devices.

Qualifications

• Minimum of four years’ experience as a microbiologist or sterilization engineer.
• Thorough knowledge of ISO 13485 and Medical Devices Directive.
• Quality management experience, including participation in third-party audits.

Responsibilities

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

Skills

Microbiology

Sterilization Engineering

Quality Management

ISO 13485

Education

Bachelor’s degree in Microbiology or related field

Job description

Overview

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

의료기기 살균기술 전문가

Location: South Korea ( homebased)

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.

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 a sterile medical device manufacturer
• Bachelor’s degree (or higher) in Microbiology, Biology or related scientific degree
• 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
• Native speaking required and local hire.

#LI-REMOTE

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.