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Senior Quality Engineer

Job Title: Senior Quality Engineer
Contract Type: Permanent
Location: Cork
Industry:
REF: 76987
Job Published: over 1 year ago

Job Description


SENIOR QUALITY ENGINEER

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 / clionaccprecruit.ie
Please Note: CCP Recruitment will not forward your details to any company without your prior approval