Medical Devices JobsSenior Supplier Quality Engineer

  • LK50941
  • Permanent
  • Clare, Limerick

Collins McNicholas

Collins McNicholas currently have an exciting opportunity for a Senior Supplier Quality Engineer with one of their clients in the Mid-West Region. This role is a permanent position.

 

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

Requirements:

  • 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%

 

For a confidential discussion and more information on the role, please contact Michael O’Leary

michael.oleary@collinsmcnicholas.ie

061512270

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