Quality Engineer required for permanent role in Offaly
- Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
- Implement continuous and innovative improvements with demonstrated and measurable results – e.g. Dock to Stock Program, Cost of Poor Quality
- Drive the supplier audit program through managing and conducting supplier audits per schedule. Ensure proper root cause is determined and implemented by the supplier when there is a finding.
- Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
- Ensure supplier files are compliant with regulations and internal procedures.
- Partner with Site purchasing & integrate Division Supplier Quality team to leverage cross site competencies and drive improvements.
- Liaise with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
- Support NPIs by providing guidance on compliant adherence to company requirements as defined in material specifications, CTQ’s, process control plans, quality agreements and other defined requirements.
- Ensure that requirements laid down in the quality manual and standard operating procedures are adhered too, and provide advice and guidance to other departments on quality related aspects.
- Provide Operational QA Support for products and process
- Degree in Quality, Engineering or a Science discipline
- 3-5 years’ experience at quality engineering level within a regulated industry
- Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations
- Audit experience in conduction supplier and or internal audits
- Ability to communicate effectively with management and fellow peers, both orally and in reports
- Knowledge in statistical methods
- Good project planning and organizational abilities
- Strong interpersonal and communications skills, including oral and written reports
- Pro-active with proven ability to work under own initiative, and strong team player
- Solid technical ability.
- Willingness to travel as part of duties
- Certified Lead auditor qualification for 13485
- Familiarity with use of ISO 14971:2007
- Experience in quality engineering in the medical devices industry
Please contact Emer Moore to discuss in confidence