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 / firstname.lastname@example.org
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