Global Technical Manager – Sterilization

This is a fully remote position, open to applicants in Romania.

📋 Description

• Supervise sterilization processes for medical devices.

• Offer technical guidance on sterilization to support all phases of the medical device conformity assessment process.

• Set competence criteria, update, deliver, and maintain suitable training programs for Product Assessors (sterilization team).

• Create, uphold, and execute sterilization QMS documentation related to the medical devices conformity assessment process.

• Serve as the primary technical reference within the designated area of responsibility.

• Monitor, analyze, and report on team performance, implementing timely corrective measures.

• Promote continuous improvement by identifying and executing process efficiencies.

• Contribute to business growth by supporting proposals, client interactions, training, and external engagements as needed.

⛳️ Requirements

• Over 10 years of experience in the medical device industry (with at least 5 years in sterile medical device research and development and/or manufacturing).

• 5 years of experience as a MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body.

• 2 years of leadership experience.

• Strong working knowledge of medical device management systems, compliance, auditing, and technical documentation assessment techniques.

• Adequate knowledge and understanding of device legislation, harmonised standards, CS, and guidance documents regarding sterilization.

• Proven experience in technical decision-making and expert-level problem-solving.

• Experience in competence management, training, or the qualification of technical personnel.

• Successful completion of a university or technical college degree or equivalent qualifications in relevant fields, such as microbiology, medicine, pharmacy, engineering, or related sciences with microbiology modules.

🏝️ Benefits

• Access to SGS university and campus for continuous learning opportunities.

• Flexible schedule with a hybrid working model.

• Benefits platform.