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Supplier Quality Engineer ll

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 18097

Our client a major Multi-National here in Galway City are looking to hire a Supplier Quality Engineer ll.

 

The Purpose:


The Quality Engineer role works with external suppliers and in a cross-functional team on a daily basis to resolve supplier related issues, drive continuous improvement while driving key quality metrics across the Galway Campus. Part of a larger team within supplier quality department, this role would support postmarket quality for components supplied to Galway.


Main Responsibilities:


  • Work closely with wider supplier quality and operation teams to drive continuous improvement and robust corrective/preventative actions through problem solving techniques at supplier to prevent recurrence of issues, and ultimately deliver high-quality products to customers
  • Ensures that suppliers deliver quality parts, materials, and services
  • Delivering cost-down projects linked directly to suppliers
  • Communicate with management and project teams on a regular basis on supplier performance
  • Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
  • Lead and provide technical assistance to suppliers/other resources performing qualification/validation testing. Ensure the resolution of all issues raised during testing/qualification.
  • Work with supplier and sub-tier suppliers, as required, to lead and drive systematic approaches and ensure stability related to medical device quality.
  • Develop strong partnerships with cross-functional groups and provide quality leadership within these groups
  • Support in the review of supplier introduction and changes, coordinating activities with suppliers and with internal cross-functional support teams to develop and implement appropriate strategies to qualify and support
  • Ensure appropriate controls are in place at supplier, based on risk associated with product or service
  • Develop and drive technical direction input to component qualification strategies and documentation in conjunction with project teams to ensure high standards are in place
  • Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
  • Define Receiving Inspection requirements as required and associated test method validation for all internal Test Methods.

Education and Competencies:


  • Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science, or technical field)
  • Minimum of 2 years relevant experience, or less with an advanced degree
  • You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210, 211, 21 CFR part 820, ICH requirements, and ISO 13485 requirements is an advantage.
  • Previous experience in Supplier Quality
  • Experience with Process Validations and/or Test Method Validations (For example IQ, OQ, PQ, and/or TMV).
  • ISO 13485 Lead Auditor Certification

For a confidential discussion and for more information please contact Michelle Mc Inerney

091 706 717

Michelle.McInenrey@collinsmcnicholas.ie