Supplier Quality Engineer - Galway (Permanent) Hybrid CREGG are now recruiting for a Supplier Quality Engineer This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway on a permanent basis workingas a Supplier Quality Engineer, in a Hybrid working role with great career progression opportunities.
Key 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 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 andrequirements.
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.
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.
Education & Experience: 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.
Good communicator skills & stakeholder engagement Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements.
ISO13485 advantageous Familiarity with Drug coated products advantageous For more details about this role get in touch Contact Gary Keane INDCRG Skills: Quality Engineer CAPA Medical devices Complaints RCA supplier Benefits: Paid Holidays Canteen Parking Pension Bonus Permanent Health Insurance