Job DescriptionAs a medical device company, we help people in a truly tangible way. We are one of the most modern electronics factories, which gives us the opportunity to develop and build a career working with the latest technologies. The knowledge and skills you'll gain here are unique, and you'll find new challenges and endless opportunities along the way.Our Fermoy, Ireland, facility is FDA registered and certified to ISO for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices. Sanmina Fermoy’s core specialization is manufacturing automation. We provide services for the entire product lifecycle from New Product Introduction (NPI), prototyping and process validation to complex volume manufacturing & test, shipping and repair. We create a state-of-the-art environment for manufacturing medical and other high-quality devices. The facility has a track record of 30 years of outstanding operational performance and customer service, backed by a highly experienced workforce.Quality EngineerObjectives Of PositionPrimary objective is to ensure customer satisfaction by monitoring, controlling and improving all related customer processes.Principal customer interface for Quality metrics and improvement initiatives. Identifies, plans, and organizes 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 Sanmina-SCI manufacturing facility.ResponsibilitiesManagement of closed loop customer complaints and improvement processes.Generation 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.MeasurementsYields at Key Process StepsCustomer Satisfaction Index, (CCN, CSO etc)Customer Return % and Cost (RMA)Scrap %Outgoing Inspection DPM & Customer Incoming Quality LevelsPERSONNEL SPECIFICATIONSEssentialUniversity Degree in Science or Engineering.At least 2 years of Quality Assurance experience in a similar Quality Engineering role.Sound understanding and utilization of Problem Solving Techniques.Proficient in the use of Microsoft Word, PowerPoint and Excel.Good Communications and influencing skills.Ability to respond to common inquiries or complaints from internal customers and regulatory agencies. Ability to write standard operating procedures, training documents, and regulatory responses.DesirableExperience in working within a Medical Device Manufacturing Environment or similar.Six sigma Green or Black Belt CertifiedExperience in New Product Introduction Processes
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