[Hiring] Global Technical Manager – Sterilization @SGS

Role Description

The role is fully remote and reports to the Head of Delivery & Operations.

• Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR.
• Act as line manager and lead the team of MDR Product Assessors-Sterilization.
• Provide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process.
• Establish competence criteria, update, deliver and maintain appropriate training packages for Product Assessors (sterilization team) as well as sterilization auditors covering all certification schemes related to sterilization within the medical device conformity assessment process.
• Develop, maintain and implement sterilization QMS documentation related to medical devices conformity assessment process of SGS NB 1639 aligned with best practices (e.g. NBOG’s BPG, MDCG guidance documents) and applicable regulatory and accreditation requirements.
• Manage the development and implementation, including approval process for Product Assessors (sterilization team) and sterilization auditors, new personnel and for ongoing monitoring and re-approval of personnel.
• Accountable for resource management within the team reporting to the role, including workload planning, capacity monitoring, and proactive identification and resolution of resource gaps – including Hubs and DO resources.
• Drive team performance against global targets, with full accountability for chargeability, utilisation, productivity, timeliness, assessment quality, and regulatory compliance – including Hubs and DO resources.
• Lead proactive decision‑making, ensuring operational and technical issues are resolved at the appropriate level with minimal escalations and delays.
• Act as a primary technical reference point within the area of responsibility, providing clear and consistent guidance to the team, Delivering Offices (DOs), and Hubs, ensuring aligned interpretation of regulatory requirements and internal procedures.
• Establish a culture of accountability and performance by setting clear expectations, defining individual and team goals, and monitoring delivery against operational and technical objectives.
• Monitor, analyse, and report team performance, implementing timely corrective actions and providing regular updates to the Head of Operations.
• Drive continuous improvement by identifying and implementing process efficiencies, capability development initiatives, and best practices within the team.
• Contribute to business growth, including supporting proposals, client interactions, training, and external engagements as required.

Qualifications

• Successful completion of a university or a technical college degree or equivalent qualifications in relevant studies, such as microbiology but can be medicine, pharmacy, engineering or relevant sciences with microbiology modules.
• Technical Manager – Sterilization candidate must be or have previously been qualified as a MDR Product Assessor and/or as MDR Lead Auditor.
• Previous medical device training (e.g. Product Specific; Standards Specific (sterilization standards, ISO 13485, ISO 14971); Directive Specific (93/42/EEC, 98/79/EC), Regulation (EU) 2017/745).

Requirements

• More than 10 years in the Medical device industry (at least 5 years within sterile medical device research and development and/or manufacturing) including experience in design, control or manufacturing and sterilization processes (microbial monitoring, packaging integrity as well as sterilization validations) of devices but as well in QMS auditing and/or technical documentation assessment covering sterilization.
• 5 years as a MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body.
• 2 years of experience in a leadership role. Demonstrated experience in technical decision‑making and expert‑level problem‑solving.
• Experience in competence management, training, or qualification of technical personnel.
• Experience supporting or leading global or cross‑functional teams.

Benefits

• Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• SGS university and Campus for continuous learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.