About the Role / Job DescriptionWe are looking for a Senior Quality Systems Engineer to join our team in Galway, supporting a growing medical device business as it transitions from a start‑up environment into a scaled, high‑volume operation. This is a hands‑on role where you will take ownership of the site Quality Management System, ensuring it remains compliant, effective, and fit for purpose. In parallel, you will play a key role in the integration of a global QMS following acquisition, helping to align ways of working while maintaining the agility and strengths of the existing site. You’ll work closely with both local teams and global stakeholders, with real opportunity to influence how quality systems evolve on site.Essential DutiesOwnership of the site QMS, ensuring ongoing compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDRLead and support core QMS processes including CAPA, Change Control, Nonconformance Management, Document Control, Internal Audits, and Management ReviewMaintain a state of audit readiness, supporting notified body and regulatory inspectionsAct as a go‑to QMS subject‑matter expert on siteSupport and lead elements of the integration of the acquiring company’s global QMSCarry out practical gap assessments and help define how best to align systems and processesDevelop and execute clear, phased integration plans, with a focus on maintaining compliance and minimising disruption to operationsWork with global teams to harmonize procedures and systems, while ensuring they are workable at site levelApply risk‑based thinking to QMS updates and integration activitiesPartner with Operations, R&D, Regulatory, and Supply Chain to ensure QMS processes are understood and effectively appliedProvide day‑to‑day support and development to direct report(s)Contribute to building a strong quality culture across the siteIdentify opportunities to simplify and improve QMS processes, particularly as the site scalesQualificationsEducationDegree in Engineering, Science, or a related discipline.Experience5+ years’ experience in a Quality role within the medical device industryStrong working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDRExperience maintaining and improving a practical, working QMS in a manufacturing environmentExposure to QMS integration, harmonization, or significant change activities would be a strong advantagePrevious experience mentoring or supporting engineers is desirableSkills / StrengthsPractical, hands‑on approach to quality systemsStrong understanding of how QMS works in a real manufacturing environmentAbility to balance compliance requirements with operational realitiesGood communicator, comfortable working across functions and levelsOrganized, with a focus on delivering clear, workable solutionsProblem solvingHighly thorough and dependableIndependent in task executionMeticulous, focus and attentive to details and accuracy in all aspects of the jobPositive attitude, able to influence and lead different groups of employee, motivate and guide people towards organizational successAnalytical minded, resourceful, statistical based decision, data driven direction, use quality tools and methodology in delivering resultsTraining / CertificationsInternational standards: ISO13485, ISO19011, ISO14971Regulatory laws: 21CFR820, 21CFR11, 21CFR803, GDPMD, Malaysia Medical Device Act 2012, Canadian MDR, EU Directive 2007/47/EC, MHLW Ord. 169, Medical Device Single Audit Program (MDSAP), EU Medical Device Regulation (EU MDR 2017/745)Physical DemandSit; use hands to finger, handle, or feel objects, tools, or controls.Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.Lifting/moving up to 10 pounds.Exposure to moving mechanical parts, vibration and/or moderate noise levels.Exposure to hazardous chemicals or other materials.
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