Global Technical Manager – Sterilization in Liverpool

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

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 on-going monitoring and re-approval of personnel.

• Maintain a full knowledge and understanding of SGS (Global System and SGS NB 1639) procedures, Best Practices Guides, MDCG Guidance Documents and external approval criteria to allow efficient and effective technical reviews.
• Ensure full compliance with the Company’s Code of Integrity, Secrecy and Non-Disclosure Agreement and act in accordance with SGS policies, procedures and processes.
• Ensure regulatory compliance of medical device technical documentation assessments under applicable regulations and schemes.
• Be a point of contact regarding queries relevant to sterilisation and support CE marking activities carried out by SGS, including support of clients’ complaints, support of delivering offices.
• Provide training, and qualification support in relation to sterilization across the SGS NB 1639 conformity assessment process, including recruitment, assessment, approval, and ongoing capability.
• Initiate and support process improvements activities as needed.
• Develop external training packages for clients by providing regulatory advice and guidance within the scope of notified body.
• Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant knowledge.
• At all times adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
• Oversee competence management activities, including the authorization of codes(qualification), monitoring, and reapproval of personnel.
• Monitor team KPIs (chargeability, utilization, productivity, timeliness, assessment quality) and support corrective actions when required.
• Perform an annual appraisal for existing team members and an appraisal after three (3) and six (6) months for new team members.
• Implementation of the performance management and disciplinary process as required.
• Support the achievement of medical devices operational and financial targets.

• Good working knowledge of medical device management systems, medical device compliance and auditing and technical documentation assessment techniques.
• Effective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues.
• Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents in regards to sterilization.
• Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices.
• Knowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria.
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Experience of management of cross functional global teams is an asset.

• 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.

• Experience working under own initiative and in planning and prioritising work.
• Good overall understanding of SGS processes and quality management system.
• Previous experience in a Notified Body or equivalent regulatory environment.
• Experience in developing technical procedures or training programmes.

• 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 previous been a 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).

Why SGS? 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.

Join Us: At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.