Global Technical Manager – Sterilization

This is a fully remote position, open to applicants in Italy.

📋 Description

• Supervise sterilization procedures for medical devices and offer technical assistance related to sterilization across various certification frameworks - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR.

• Serve as line manager and guide the team of MDR Product Assessors specializing in Sterilization.

• Provide expert technical guidance on sterilization to facilitate all phases of the medical device conformity assessment process.

• Define competence criteria, update, create, and maintain suitable training programs for Product Assessors (sterilization team) and sterilization auditors.

• Develop, uphold, and execute sterilization Quality Management System documentation pertinent to the medical devices conformity assessment process of SGS NB 1639, aligned with industry best practices.

⛳️ Requirements

• Over 10 years of experience in the medical device sector (minimum of 5 years in sterile medical device research and development and/or manufacturing).

• 5 years of experience as a Lead Auditor/Product Assessor for MDR and/or IVDR medical devices within a Notified Body, focusing on Sterilization.

• 2 years of experience in a leadership capacity.

• Proven track record in technical decision-making and expert-level problem-solving.

• Experience in competence management, training, or qualifying technical personnel.

• Background in supporting or leading global or cross-functional teams.

🏝️ Benefits

• Flexible scheduling and a hybrid work model.

• Access to SGS university and Campus for ongoing learning opportunities.

• Comprehensive benefits platform.