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Global Technical Manager – Sterilization

ManagerManagerFull TimeRemoteLeadTeam 10,001+Since 1878H1B SponsorCompany SiteLinkedIn

Location

Ireland

Posted

1 day ago

Salary

0

Seniority

Lead

Postgraduate Degree10 yrs expEnglish

Job Description

Global Technical Manager – Sterilization

SGS

• Oversee sterilization processes within medical devices and provide technical support related to sterilization across all certification schemes • 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 • Develop, maintain and implement sterilization QMS documentation related to medical devices conformity assessment process • Manage the development and implementation, including approval process for Product Assessors and sterilization auditors • Monitor, analyse, and report team performance, implementing timely corrective actions and providing regular updates to the Head of Operations

Job Requirements

  • More than 10 years in the Medical device industry (at least 5 years within sterile medical device research and development and/or manufacturing)
  • 5 years as a MDR and/or IVDR medical device Lead Auditor / Product Assessor – Sterilization within a Notified Body
  • 2 years of experience in a leadership role
  • Good working knowledge of medical device management systems, medical device compliance and auditing and technical documentation assessment techniques
  • Appropriate knowledge and understanding of devices legislation as well as harmonised standards, CS and guidance documents in regards to sterilization
  • Appropriate knowledge and understanding of the conformity assessment procedures provided for in the regulations for medical devices
  • Experience supporting or leading global or cross‑functional teams.

Benefits

  • Flexible schedule and hybrid model
  • SGS university and Campus for continuos learning options
  • Benefits platform

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