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.
- 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