lavori in località Gqeberha (Sud Africa)

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.