Global Technical Manager – Sterilization

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.

Essential

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.

Desirable

Experience working under own initiative and in planning and prioritising work.

Experience of management of cross functional global teams is an asset.

Good overall understanding of SGS processess 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).

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 continuos 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.