Global Technical Manager – Sterilization

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

📋 Description

• Oversee the sterilization procedures for medical devices and offer technical assistance related to sterilization across all certification frameworks.

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

• Provide technical counsel regarding sterilization to aid all phases of the medical device conformity assessment process.

• Set competence standards, refresh, deliver, and uphold suitable training programs for Product Assessors and sterilization auditors.

• Create, sustain, and execute sterilization QMS documentation pertinent to the medical device conformity assessment process of SGS NB 1639.

• Oversee the development and execution, including the approval process for Product Assessors (sterilization team) and sterilization auditors.

• Monitor, analyze, and report on team performance metrics.

• Propel continuous improvement by recognizing and implementing process efficiencies, capability development initiatives, and best practices within the team.

• Act as the senior technical authority for the designated scope, ensuring uniform interpretation and application of regulatory and internal standards.

⛳️ Requirements

• Over 10 years of experience in the medical device sector (with a 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.

• At least 2 years of experience in a leadership capacity.

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

• Experience in managing competence, training, or qualification of technical staff.

• Background 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.

• Work in a multinational environment alongside colleagues from various continents.