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Supplier Quality Engineer III

  • Division: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 24011

Our client a major multinational based here in Galway are e are seeking a Supplier Quality Engineer III to join their team.

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The Role:

As the Supplier Quality Engineer you will collaborate with cross-functional teams and suppliers to address quality concerns for PI divisional products, playing a key role in enhancing supplier performance and strengthening their ability to consistently meet standards.

Additionally, this position offers the opportunity to participate in supplier-related projects across the global supplier quality management network. Some travel will be required to support and engage with suppliers effectively.

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Responsibilities:

  • Responsible for quality performance of Sourced Finished Medical Device manufacturers (OEM and Contract Manufacturers)

  • Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, risk assessing, prioritizing, and resolving quality issues.

  • Investigates and solves non-conformances due to incoming inspection at Distribution Centers

  • Supports investigation of material Quality issues/ complaints as they arise and ensures that adequate Corrective Actions are identified, implemented and controlled by Suppliers

  • Reviews and approves supplier corrective action plans and verification of effectiveness documentation through SCAR ownership

  • Plans and leads supplier assessment to assess compliance with regulatory standards and Boston Scientific requirements.

  • Technical Team Member partnering with Supplier Engineering and Commercial Sourcing for multiple aspects of Supplier Management supporting objectives of the team in terms of Quality, Cost and Service including Supplier originated changes, design and labelling changes.

  • Supports sustaining quality issues, process change impacts, and design change implementations for suppliers within their Quality system, and in the Quality System.

  • Team member of New Product Development (NPD) projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.

Requirements:

  • Level 8 Degree in an Engineering or Technical Discipline

  • 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation and CAPA.

  • Ability to work independently; organized and self-driven.

  • A strong communicator (written and verbal) who can effectively organize, present and explains data/ information with all internal & external stakeholders.

  • Competency in Microsoft software systems e.g. MS Excel, PowerPoint, Power BI and in QMS software systems (CAPA, SCAR etc)

  • Domestic and international travel up to 25%.

Preferred Qualifications:

  • Prior experience within a quality function, preferably supplier quality.

  • Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.

  • Lead Assessor ISO13485 certification preferred.

  • Familiarity with Drug coated products advantageous

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717