Global Technical Manager (Sterilization)

TL;DR

Global Technical Manager (Sterilization): Oversee sterilization processes for medical devices and provide technical support across MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR conformity assessment schemes with an accent on leading a sterilization assessor/auditor team and building sterilization QMS documentation. Focus on competence management, regulatory-aligned technical decision-making, and driving operational performance with minimal escalations.

Location: Remote

Company

hirify.global is a global testing, inspection, and certification company.

What you will do

• Oversee sterilization processes for medical devices and provide technical support across all relevant certification schemes.
• Act as line manager for the MDR Product Assessors – Sterilization team and serve as a primary technical reference point.
• Establish and maintain training packages, competence criteria, and authorization/monitoring/re-approval processes for sterilization assessors and auditors.
• Develop and implement sterilization QMS documentation aligned with hirify.global NB 1639 and applicable regulatory/accreditation requirements.
• Drive global operational performance: resource planning, capacity monitoring, chargeability/utilisation/productivity/timeliness, assessment quality, and regulatory compliance.
• Support business growth through proposals, client interactions, training, and external engagements as required.

Requirements

• More than 10 years in the medical device industry, including at least 5 years in sterile medical device R&D and/or manufacturing and experience with sterilization processes (e.g., microbial monitoring, packaging integrity, sterilization validations) plus QMS auditing and/or technical documentation assessment covering sterilization.
• 5 years as an MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body.
• 2 years of experience in a leadership role with demonstrated technical decision-making and expert-level problem-solving.
• Experience in competence management, training, or qualification of technical personnel.
• Experience supporting or leading global/cross-functional teams.
• University or technical college degree in relevant studies (e.g., microbiology; or medicine/pharmacy/engineering with microbiology modules).

Culture & Benefits

• Flexible schedule with a hybrid model.
• Global and stable company environment with multinational collaboration across continents.
• hirify.global university and Campus options for continuous learning.
• Benefits platform.