Remote Global Sterilization Manager

SGS Italia; Desio; Remote; EUR 90,000 - 130,000; Full time

Job summary

SGS Italia is seeking a Technical Manager – Sterilization to lead the Sterilization team in medical device conformity assessment. This fully remote role reports to the Head of Delivery & Operations and requires deep sterilization knowledge across MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR.

You will establish competence criteria, deliver training, develop sterilization-related QMS documentation, and ensure regulatory compliance.

Qualifications

• More than 10 years in the medical device industry with sterilization experience.
• 5 years as MDR/IVDR Lead Auditor or Product Assessor – Sterilization.
• 2 years in a leadership role.
• Experience managing global cross-functional teams.

Responsibilities

• Oversee sterilization processes within medical devices and provide technical support across schemes (MDR, MDD, UK MDR, ISO13485, MDSAP, IVDR).
• Lead the MDR Product Assessors-Sterilization team and supervise auditors.
• Develop, maintain and implement sterilization-related QMS documentation for the conformity assessment process.
• Provide training, recruitment, assessment, approval, and ongoing capability of personnel.
• Monitor KPIs (chargeability, utilization, productivity, timeliness, assessment quality) and drive continuous improvement.

Skills

Sterilization

Regulatory knowledge

Auditing leadership

Team leadership

Cross-functional leadership

Education

University degree in microbiology/engineering

Job description

SGS Italia is seeking a Technical Manager – Sterilization to lead the Sterilization team in medical device conformity assessment. This fully remote role reports to the Head of Delivery & Operations and requires deep sterilization knowledge across MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR.

You will establish competence criteria, deliver training, develop sterilization-related QMS documentation, and ensure regulatory compliance.