Global Technical Manager – Sterilization

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

📋 Description

• Supervise sterilization processes for medical devices and offer technical assistance related to sterilization across all certification schemes.

• Serve as the line manager and lead the team of MDR Product Assessors-Sterilization.

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

• Establish competence criteria, and create, deliver, and maintain suitable training programs for Product Assessors.

• Develop, sustain, and execute sterilization QMS documentation pertinent to the medical devices conformity assessment process.

• Oversee the development and execution of processes, including the approval process for Product Assessors and sterilization auditors.

• Monitor, evaluate, and report on team performance, taking timely corrective actions and providing routine updates to the Head of Operations.

⛳️ Requirements

• Over 10 years of experience in the medical device industry (with at least 5 years in sterile medical device research and development and/or manufacturing).

• 5 years as a MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body.

• Minimum of 2 years in a leadership capacity.

• Strong working knowledge of medical device management systems, compliance, auditing, and technical documentation assessment techniques.

• Adequate knowledge and understanding of device legislation and relevant harmonised standards, CS, and guidance documents concerning sterilization.

• Solid understanding of the conformity assessment procedures as outlined in the regulations for medical devices.

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

🏝️ Benefits

• Flexible schedule and hybrid work model.

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

• Comprehensive benefits platform.