Collins McNicholas

Edwards Lifesciences has an exceptional opportunity for a Senior Engineer with the Supplier Quality group.

This person will be responsible for supplier quality vendor management, audits, and improvements while supporting continued Quality System improvements.

In this position you will support activities sustaining quality engineering within Receiving Inspection, Manufacturing, and Product Verification as applied to supplier related issues.

 

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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