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Supplier Quality Engineer

Job Title: Supplier Quality Engineer
Contract Type: Permanent
Location: Cork
REF: 79027
Job Published: over 2 years ago

Job Description


Our client a leading medical device company based in Cork, requires a Supplier Quality Engineer for a permanent job.

  • Provide Quality Leadership in support of External Manufacturing Outsourcing programs
  • Ensure External Manufacturers continue to meet Quality requirements with regard to Supplier Change Request process of the company
  • Develop supplier capability in risk assessment such as PFMEA
  • Actively support all defined External Manufacturing Quality Systems goals and objectives.
  • Represent Quality at Supplier Business Review Meetings
  • Conduct on-site quality and process assessments at suppliers both to approve new suppliers and on and ongoing basis
  • Promote continuous improvement and Process Excellence activities within the Global Supply Chain
  • Review and approve Validation of new/changed production processes as required
  • Design and validate Quality System processes where appropriate (CSV and Inspection Process)
  • Resolve problems & eliminate constraints to ensure project and supply targets are met.
  • Generate Quality metrics on supplier performance and establish measures to monitor quality costs and cost avoidance
  • Communicate and assure appropriate implementation of Quality Process Specifications (QPS), Quality Control Test Specifications (QCTS), and Raw Material Specifications (RMS) etc.
  • Ensure effective and timely closure on all Supplier Corrective Action Requests.

Education, Experience and Skills
  • Level 8 Bachelor's Degree is required. A Degree in Engineering, Life Science, or related discipline is preferred.
  • Minimum 3/4 years? experience in a Quality or Engineering Function within a Medical Device Company.
  • Experience in the medical device, biotech and/or pharmaceutical industry is preferred. Both, FDA and ISO (International Organization for Standardization) regulations knowledge is required FDA CFR Part 820 and/or ISO 13485 knowledge is preferred
  • Strong in root cause analysis skills
  • Possess knowledge of statistical analysis tools (Minitab SAS preferred).
  • Process Excellence ? Green/Black belt certification

For further information on this Supplier Quality Engineer role in Cork please contact Cliona O?Malley on 091730022 /
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