If you are looking for a challenging opportunity to work in an international environment, then we may have a job for you. We are looking for a self-starter and enthusiastic Senior Quality Engineer to join our Global Quality Assurance team for a 12 month contract. Location: Gort, Co. Galway. This role can be hybrid (3 days onsite)
Welcome to Natus Medical Incorporated: We're the leading manufacturer of medical devices and software for a range of specialities, including new-born care, neurology, sleep, hearing and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufacture and distribute a range of medical device products used in the diagnosis of human neurological disorders.
Job Overview: The Senior Quality Engineer is a vital role aboard our Quality Assurance team to help drive process improvement initiatives and streamlining efforts of quality management systems. You can expect to be hands on supporting product development teams with design transfer activities, managing, and closing out CAPAs, and ensuring quality compliance for a diverse product portfolio.
Support of Clean Room (Class 8) procedures and controls and Environmental MonitoringCo-ordination of Sterilisation programme for sterile products (including Dose audit program)Provides support to product development and sustaining teams including but not limited to design input/output, verification/validation, risk management, and design transfer activitiesDrives streamlining improvement initiatives in the Quality Management system across the siteEnsures quality system compliance to ISO13485, 21CFR 820, MDSAP and Medical Device RegulationsPrepares metrics in support of trending and management reviewsProvides quality inputs in product design updates and support design maintenance releasesConducts internal audits when needed and serves as Quality System support for Regulatory and Corporate AuditsTakes ownership of managing and closing out CAPAs where required.Guides product transfer activities and streamlining of quality management systemsStays up-to-date and follows all Quality System procedures related to this job, which can affect the quality of products or services provided to our customersEducation and/or Experience: Requirement: Third level degree in science e.g. Biopharmaceutical Science/Microbiology/Chemistry or similar4-6 years of experience in Microbiology or Quality Assurance in the medical device industry, including experience with design controls and design transfer activitiesCompetent working knowledge of recognized Quality Management Systems and Global Medical Device regulations (e.g. ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)Strong CAPA experienceExperience of sterile products in a medical device or pharmaceuticalsDemonstrated excellent organizational skills and ability to work on own initiative essential.Excellent written, documentation, and oral communication skills and are fluent in English, both written and spokenHere's what you can expect: A competitive salary packageComprehensive Healthcare & Life Assurance coverageAdditional benefits such as income protection and death in service benefit.Health & Wellbeing EventsRecognition SchemeFree parkingEducational assistanceEEO Statement Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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