Global Technical Manager – Sterilization

Overview

In this remote role, you will oversee sterilization processes for medical devices across certification schemes and lead the Sterilization MDR Product Assessors. You’ll set competence criteria, deliver training, and maintain sterilization QMS aligned with regulatory guidance. As a member of Global Operations Leadership, you’ll optimize resources, drive performance and ensure compliance. You’ll act as the technical reference for sterilization, supporting proposals, client interactions and external engagements. This position offers global exposure, development opportunities and a strong impact on product conformity and patient safety.

Pay / Benefits

• flexible schedule
• hybrid model
• SGS university and continuous learning
• multinational environment
• benefits platform
• career development opportunities

Responsibilities

• Oversee sterilization processes for medical devices across MDR, IVDR, and related schemes
• Lead and manage the MDR Product Assessors-Sterilization team
• Provide technical advice throughout the conformity assessment process
• Develop and maintain competence criteria; deliver training for assessors and auditors
• Maintain sterilization-related QMS documentation aligned with NB 1639 and MDCG guidance
• Manage onboarding, monitoring, and re-approval of personnel
• Monitor team KPIs and drive corrective actions
• Support proposals, client interactions, and external engagements
• Act as senior technical authority for assigned scope; resolve complex issues
• Drive continuous improvement, process efficiency and best practices
• Participate in risk management, safety and regulatory compliance activities
• Prepare and deliver reports on team performance to Head of Operations
• Support business growth through technical input for client engagements

Key requirements

• >10 years in medical device industry with sterilization experience
• 5+ years as MDR Lead Auditor / Product Assessor – Sterilization within a Notified Body
• 2+ years in a leadership role
• Experience in QMS auditing and technical documentation assessment
• Experience leading global or cross-functional teams
• Strong knowledge of sterilization standards and regulatory requirements

• Interpersonal skills
• Relationship building
• Problem-solving
• Sterilization process knowledge (microbial monitoring, packaging integrity, sterilization validations)
• MDR/IVDR regulatory understanding
• NB 1639 requirements and conformity assessment procedures

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