Description
My client, an innovative technology leader, is currently recruiting for a Quality Engineer to join their team in Co. Cork. Reporting to the Quality Manager, the successful candidate will act to ensure customer satisfaction by monitoring, controlling and improving all related customer processes. Be the principal customer interface for Quality metrics and improvement initiatives as well as identify, plan, and organize regulatory affairs for ensuring compliance with the FDA's Quality System Regulations, ISO 9000, ISO 13485:2003, JPAL, as well as all international standards relevant to customer products for my clients manufacturing facility.Responsibilities:
- Management of closed loop customer complaints and improvement processes.
- Generation and Review and review of Quality Metrics System.
- Overall responsibility for DMR/DHR and Technical Files.
- Data collection, analyzing and reporting.
- Pareto and trend analysis.
- Initiate and drive Continuous Improvement programs.
- NPI Approval including First Article Inspections and Reporting.
- CAPA, NCM and RMA analysis and Improvement.
- QSR Validation protocols and report (IQ, OQ & PQ).
- Conducting Audits to ensure conformance and effectiveness of the Quality System.
- Carry out measurements using: Yields at Key Process Steps, Customer Satisfaction Index, (CCN, CSO etc), Customer Return % and Cost (RMA), Scrap %, Outgoing Inspection DPM and Customer Incoming Quality Levels
- Batch review records and batch release experience.
- Sound understanding and utilization of Problem Solving Techniques
Experience:
- Degree / Diploma in Science or Engineering, or a lesser qualification with sufficient job related experience
- At least 4-5 years Quality Assurance / Regulatory affairs experience, in a similar Quality Engineering role in the electronics manufacturing industry.
- Operational knowledge of Clean Room.
- Knowledge of sterilization esp. EO and EBEAM.
- Experience of Bioburden and Endotoxin testing of both clean room and product.
- Ability to write standard operating procedures, training documents, and regulatory responses.
- Experience working within a Class 3 Medical Device Manufacturing Environment.
- Six sigma Green or Black Belt Certified
- Experience in New Product Introduction Processes
If you feel you would be a good fit for this role please apply directly, or for immediate consideration call me, Derek Sheridan, on .
Sthree UK is acting as an Employment Agency in relation to this vacancy.