Do you want to help improve the lives of millions of people?We are developing cutting edge technology to reinvent the treatment of heart failure globally. If you are interested in joining a dynamic team that is working hard to change the world for the better, we'd love to talk to you.As a Senior Quality Engineer, you will lead the day-to-day implementation and maintenance of the Quality Management System (QMS), with a strong emphasis on continuous improvement. Provide quality support across manufacturing, supply chain, and design assurance functions. Act as a cross-functional representative of the Quality team, driving collaboration and alignment across departments.ResponsibilitiesDrive the day to day implementation of the QMSEnsure delivery of overall quality strategy & support achievement of the business quality objectivesCollaborate with wider team to ensure necessary QA activities are planned, executed and documentedInterpret relevant standards and ensure company meets requirementsDevelop and review test specifications, part specifications & design specifications with cross functional teamSupport manufacturing team activities associated with manufacturing in a regulated environment e.g. equipment qualification, process validation and change controlProvide practical QA and Design Assurance expertiseSupport supply chain in supplier related activities e.g. process development and manufacturing requirementsCoordinate and manage key activities such as internal audit programme, material review board, NC/CAPA review board, complaint processProject support for regulatory submissionsSupport clinical investigationsQualifications & ExperienceBachelor’s Degree in Engineering, Science or related field5+ years’ experience in medical device quality/design assurance roleRecent regulatory experience including FDA regulations, ISO 13485, Medical Device Directive and other applicable national and international regulations and standardsMaster’s degree in Engineering, Science or related fieldExperience in implantable medical devicesExperience with process development and change management in regulated environmentReporting: This role reports to the Quality Systems ManagerBenefits25 days annual leaveCompetitive health insurance plan with VHIPension 8% employer contributionEmployee share ownership programmeDiscretionary bonus planDiscounted gym membership at DCU & UCD gymsTaxsaver Commuter Tickets & Bike to Work SchemeEAP (Employee Assistance Programme)Employer funded Sports & Social CommitteeSeniority levelMid-Senior levelEmployment typeFull-timeJob functionQuality AssuranceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at FIRE1 by 2x
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