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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Cork
REF: 76987
Job Published: over 2 years ago

Job Description


Our client requires an experienced Senior Quality Engineer who will be responsible for providing quality assurance leadership in the management of key external manufacturers.

Key Responsibilities
  • Quality point of contact for Global Supply Chain with External Manufacturers.
  • Provide quality leadership to improve the technical and quality competency of the External Manufacturers.
  • Develop and implement Quality Improvement Programs with External Manufacturers.
  • Liaise with internal stakeholders to ensure that External Manufacturers Process Changes are adequately assessed.
  • Provide technical and validation guidance to External Manufacturers to ensure that process changes are adequately validated/qualified.
  • Drive improvement of the External Manufacturers capability in risk assessment to reduce risk within manufacturing process.
  • Provide technical guidance in developing the release criteria for non-conforming product, ensuring effective and timely closure on all corrective action requests.
  • Actively develop and support all defined External Manufacturing Quality Systems goals and objectives.
  • Liaise with External Manufacturers to develop quality metrics to measure performance and establish measures to monitor quality costs and cost avoidance.
  • Lead the resolution of problems & eliminate constraints to ensure project and supply targets are met.
  • Quality Lead at External Manufacturer Business Review Meetings
  • Conduct on-site quality and technical process assessments at External Manufacturers.
  • Promote continuous improvement and process excellence activities within the Global Supply Chain
  • Facilitate the completion of the quarterly Supplier Management Committee meeting

Education, Experience and Skills

  • Minimum of a Bachelor's Degree is required in Engineering, Life Science, or related discipline is preferred.
  • Minimum 5-6 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 validation experience, root cause analysis
  • Flexible to travel
  • Strong communication, teamwork, and problem solving skills are required.
  • Possess knowledge of statistical analysis tools (Minitab SAS preferred).
  • Process Excellence ? Green/Black belt certification
  • ISO 9001 Internal/External Auditor or ASQ Certification as an Auditor.
  • Project management experience.

For further information please contact Cliona O?Malley on 091730022 /
Please Note: CCP Recruitment will not forward your details to any company without your prior approval