Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

Edwards Lifesciences

Shannon, Ireland

Responsibilities:

  • Audit, monitor, evaluate, report and improve supplier Quality system performance and provide technical support to suppliers.
  • Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action.
  • Collect and add supplier information required for the Approved Supplier List.
  • Conduct component and product Quality testing for purposes of supplier and component qualification and improvement.
  • Identify and implement statistical engineering tools and techniques to evaluate supplier process capability and technical performance.
  • Evaluate supplier Quality systems, strategies and regulatory compliance via vendor audits.
  • Collect and analyze Quality metrics relating to Supplier Quality.
  • Identify and define correction actions and follow-up to ensure completeness and effectiveness.
  • Communicate supplier Quality risks to upper management while suggesting improvements and cost savings where possible.

Required Skills:

  • Bachelors Science degree (Engineering or Science) is required with 4 years minimum experience in the medical device required, pharmaceutical industry experience may be considered.
  • Experience with class II and class III medical devices a plus.
  • Demonstrated ability to apply statistical Quality engineering tools in a supplier environment.
  • Working knowledge of International and Domestic FDA regulations.
  • Effective communication and conflict resolution skills.
  • Effective problem solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.).
  • Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s.
  • Strong understanding of Manufacturing processes (i.e. Injection Molding, Extrusion, and Machining).
  • Thorough understanding of Risk Management principles.
  • Strong communication and organizational skills to effectively manage and get results with external suppliers.
  • Six Sigma Black Belt/LEAN Manufacturing experience preferred.
  • Certified Quality Auditor.
  • Domestic and International Travel upwards of 25%.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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