Global Technical Manager – Sterilization

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pWe 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. /ppAt 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. /ppThe role is fully remote and reports to the Head of Delivery Operations /ph3Main Purpose of Role /h3ulliOversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes - MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR. /liliAct as line manager and lead the team of MDR Product Assessors-Sterilization. /liliProvide technical advice in relation to sterilization to support all stages of the medical device conformity assessment process /liliEstablish 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. /liliDevelop, 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. /liliManage 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. /li /ulh3In addition to above, as member of the Global Operations Leadership Team: /h3ulliAccountable 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. /liliDrive team performance against global targets, with full accountability for chargeability, utilisation, productivity, timeliness, assessment quality, and regulatory compliance – including Hubs and DO resources. /liliLead proactive decision‑making, ensuring operational and technical issues are resolved at the appropriate level with minimal escalations and delays. /liliAct 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. /liliEstablish a culture of accountability and performance by setting clear expectations, defining individual and team goals, and monitoring delivery against operational and technical objectives. /liliMonitor, analyse, and report team performance,



implementing timely corrective actions and providing regular updates to the Head of Operations. /liliDrive continuous improvement by identifying and implementing process efficiencies, capability development initiatives, and best practices within the team. /liliContribute to business growth, including supporting proposals, client interactions, training, and external engagements as required. /li /ulh3Key Accountabilities – Sterilization /h3ulliMaintain 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. /liliEnsure regulatory compliance of medical device technical documentation assessments under applicable regulations and schemes /liliBe 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. /liliProvide training, and qualification support in relation to sterilization across the SGS NB 1639 conformity assessment process, including recruitment, assessment, approval, and ongoing capability. /liliInitiate and support process improvements activities as needed. /liliDevelop 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. /liliAt 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. /liliOversee competence management activities, including the authorization of codes(qualification), monitoring, and reapproval of personnel /liliMonitor team KPIs (chargeability, utilization, productivity, timeliness, assessment quality) and support corrective actions when required. /liliPerform 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. /liliSupport the achievement of medical devices operational and financial targets. /liliIn addition to that as member of the Global Operations Leadership Team additional responsibilities as below: /liliAct as the senior technical authority for the assigned scope, ensuring consistent interpretation and application of regulatory and internal requirements. /liliProvide expert technical support to team members, DOs, and Hubs,



including resolution of complex technical issues and escalations. /liliLead the development, maintenance, and implementation of technical procedures, guidance documents, and training materials. /liliSupport business development activities by providing technical input for proposals, client interactions, and external events. /li /ulh3Skills Knowledge /h3ulliGood working knowledge of medical device management systems, medical device compliance and auditing and technical documentation assessment techniques. /liliEffective interpersonal skills, able to develop good working relationships with medical device teams and delivering office colleagues. /liliAppropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents in regards to sterilization. /liliAppropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices. /liliKnowledge and experience with the NB’s quality management system, related procedures and the required qualification criteria. /liliThe ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out. /liliExperience of management of cross functional global teams is an asset. /li /ulh3Experience /h3h3Essential /h3ulliMore 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. /lili5 years as a MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body. /lili2 years of experience in a leadership role. Demonstrated experience in technical decision‑making and expert‑level problem‑solving. /liliExperience in competence management, training, or qualification of technical personnel. /liliExperience supporting or leading global or cross‑functional teams. /li /ulh3Desirable /h3ulliExperience working under own initiative and in planning and prioritising work. /liliExperience of management of cross functional global teams is an asset. /liliGood overall understanding of SGS processess and quality management system. /liliPrevious experience in a Notified Body or equivalent regulatory environment. /liliExperience in developing technical procedures or training programmes. /li /ulh3Additional information /h3ulliSuccessful 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. /liliTechnical Manager – Sterilization candidate must be or have previous been a qualified as a MDR Product Assessor and/or as MDR Lead Auditor. /liliPrevious 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). /li /ul #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8oo2s9