Quality Engineer required for permanent role in Offaly

Key Responsibilities:

  • Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
  • Implement continuous and innovative improvements with demonstrated and measurable results – e.g. Dock to Stock Program, Cost of Poor Quality
  • Drive the supplier audit program through managing and conducting supplier audits per schedule. Ensure proper root cause is determined and implemented by the supplier when there is a finding.
  • Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
  • Ensure supplier files are compliant with regulations and internal procedures.
  • Partner with Site purchasing & integrate Division Supplier Quality team to leverage cross site competencies and drive improvements.
  • Liaise with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
  • Support NPIs by providing guidance on compliant adherence to company requirements as defined in material specifications, CTQ’s, process control plans, quality agreements and other defined requirements.
  • Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality related aspects.
  • Provide Operational QA Support for products and process

 

Requirements: 

  • Degree in Quality, Engineering or a Science discipline
  • 3-5 years’ experience at quality engineering level within a regulated industry
  • Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations
  • Audit experience in conduction supplier and or internal audits
  • Ability to communicate effectively with management and fellow peers, both orally and in reports
  • Knowledge in statistical methods
  • Good project planning and organizational abilities
  • Strong interpersonal and communications skills, including oral and written reports
  • Pro-active with proven ability to work under own initiative, and strong team player
  • Solid technical ability.
  • Willingness to travel as part of duties

 

Advantageous:

  • Certified Lead auditor qualification for 13485
  • Familiarity with use of ISO 14971:2007
  • Experience in quality engineering in the medical devices industry

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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