Device Assurance Lead

2 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time

A Senior Manager Device Supplier Assurance plays a critical role in a leading global life science business in Dublin. This position is responsible for conducting supplier audits, generating and managing Supplier Control SOPs, and creating Quality Technical Agreements and contractual agreements for CMOs and service providers.

Key Responsibilities
  • Main point of contact for communications, escalation, and resolution of supplier-related quality and technical issues that may impact program timelines or contractual obligations.
  • Conduct supplier technical assessments identified as technical capability for potential business opportunities.
  • Maintain a supplier technical assessment schedule and approved supplier list against business needs.
  • Support the generation of projects, purchasing/supplier specifications.
  • Manage & execute supplier-related change controls and supplier complaints.
Requirements
  • Degree in Engineering/Biomedical Science, Engineering, or equivalent.
  • A qualified Supplier Auditor with strong supplier audit experience.
  • Proven experience within a medical device supplier lead role.
  • Experience within a medical devices and container closure systems environment with emphasis on drug delivery technologies would be a distinct advantage.
  • Experience of supplier evaluation & selection against technical need.
  • Excellent technical report writing skills.
  • Willingness to travel (Around 20%).


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