Global Technical Manager – Sterilization

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ff1yu

Job Description
The role is fully remote and reports to the Head of Delivery & Operations
Main Purpose of Role
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 ( 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. In addition to above, as member of the Global Operations Leadership Team:
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, provid

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ff1yu