SGS
Global Technical Manager – Sterilization
Ellesmere Port
Posted 8 days ago
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Global Technical Manager – Sterilization
Technical Manager – Sterilization
About SGS
The world's leading testing, inspection, and certification (TIC) company, we are the global benchmark for sustainability, quality, and integrity. Our 99,600 employees operate across 2,600 offices and laboratories, enabling a safer, interconnected world.
At SGS, we foster:
- An open, international corporate culture
- A dynamic work environment in a leading global company
- High professional standards and a sustainability-driven approach
- Long-term investment in employee development aligned with our principles:
- Integrity
- Health, Safety & Environment
- Quality & Professionalism
- Respect
- Sustainability
- Leadership
Job Description
This is a fully remote role, reporting to the Head of Delivery & Operations.
Main Purpose of the Role
- Oversee sterilization processes within medical devices, providing technical support across all certification schemes (MDR, MDD, UK MDR, ISO 13485, MDSAP, IVDR).
- Act as a line manager and lead the MDR Product Assessors – Sterilization team.
- Provide technical advice on sterilization to support all stages of the medical device conformity assessment process.
- Develop and maintain competence criteria, deliver training packages, and ensure compliance with SGS NB 1639 standards.
- Manage personnel approvals, training, and ongoing monitoring for Product Assessors and sterilization auditors.
- Lead Global Operations Leadership Team responsibilities, including:
- Resource management (workload planning, capacity monitoring, gap resolution)
- Team performance accountability (chargeability, utilization, timeliness, quality, compliance)
- Decision-making & escalation management
- Technical stewardship for consistent regulatory guidance
- Culture of accountability (goal-setting, performance monitoring)
- Continuous improvement (efficiency, capability development)
- Business growth support (proposals, client interactions, external engagements)
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Key Accountabilities
Sterilization Focus
- Maintain expertise in SGS procedures, best practices, MDCG guidance, and approval criteria for technical reviews.
- Ensure regulatory compliance of medical device conformity assessments.
- Serve as the primary contact for sterilization queries, CE marking activities, and client complaints.
- Develop external training packages and support technical qualifications.
- Lead competence management, including personnel authorization, monitoring, and reapprovals.
- Monitor team KPIs (chargeability, utilization, productivity, compliance) and implement corrective actions.
- Conduct annual & quarterly appraisals and manage performance/disciplinary processes.
- Contribute to operational & financial success of medical device operations.
Global Operations Leadership
- Provide senior technical authority for assigned scope.
- Support team members, Delivering Offices (DOs), and Hubs in resolving complex technical issues.
- Develop procedures, guidance documents, and training materials.
- Assist in business development (proposals, client engagements, events).
Skills & Knowledge
Essential
- Proficient in medical device management systems, compliance, auditing, and technical documentation.
- Strong interpersonal skills for collaboration with global teams.
- Deep understanding of sterilization legislation, standards (ISO 13485, ISO 14971), and guidance documents.
- Knowledge of conformity assessment procedures and QMS quality systems.
- Ability to author comprehensive assessment reports.
- Proven experience in global cross-functional team leadership.
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Desirable
- Self-organization & work prioritization skills.
- Familiarity with SGS processes and quality management systems.
- Background in Notified Bodies or regulatory environments.
- Expertise in technical procedure development or training program design.
Experience
Essential
- 10+ years in the medical device industry, with 5+ years focused on sterile medical devices (sterilization validations, microbial monitoring, packaging integrity).
- 5+ years as an MDR/IVDR Lead Auditor or Product Assessor for Sterilization in a Notified Body.
- 2+ years in a leadership role, demonstrating technical problem-solving and decision-making.
- Experience in competence management, training, or qualification of technical personnel.
- Track record of leading global or cross-functional teams.
Desirable
- Independent initiative in planning and prioritization.
- Experience with cross-functional global team leadership.
- Knowledge of SGS internal processes.
Qualifications
- University/college degree (or equivalent) in relevant sciences (microbiology, medicine, pharmacy, engineering).
- Qualification as an MDR Product Assessor &/or Lead Auditor (or pursuit of status).
- Medical device training in:
- Product-specific standards
- Sterilization-related certifications (ISO 13485, ISO 14971)
- Directive/Regulation experience (MDR/IVDR, 93/42/EEC, 2017/745)
Why Join SGS?
- Global stability as the world leader in TIC.
- Flexible/hybrid work model.
- SGS University & Campus for continuing professional development.
- Multinational team environment.
- Comprehensive benefits package. (Add benefits section comment if required)
At SGS, we believe in innovation, collaboration, and growth in a supportive and inclusive environment.
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Skills
Medical Device Compliance
Technical Documentation Assessment
Sterilization Processes
Quality Management Systems
Regulatory Compliance
Training Development
Team Leadership
Interpersonal Skills
Problem-Solving
Resource Management
Continuous Improvement
Client Interaction
Process Efficiency
Competence Management
Microbial Monitoring
Sterilization Validation