Global Technical Manager – Sterilization

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).

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 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.

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.

Originally posted on Himalayas

• 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.