{"schemaVersion":"jobsearcher.job.v1","id":"a4e4287bd7f21885936fc4a9","url":"https://jobsearcher.com/jobs/a4e4287bd7f21885936fc4a9","canonicalUrl":"https://jobsearcher.com/jobs/a4e4287bd7f21885936fc4a9","title":"Quality Engineer","description":"Overview\nIn this role you support R&D and Process Engineering to ensure design controls and risk management are integrated into product development. You will help maintain and improve the QMS to meet regulatory requirements and internal practices. You address quality issues and drive risk-based decisions across design, manufacturing, and verification activities. Your work focuses on patient safety, compliance, and delivering high-quality medical devices.\n\nResponsibilitiesIdentify and implement QC systems to support manufacturing and product developmentImprove and streamline quality practices to resolve issuesApply systematic problem-solving to prioritize and resolve quality issuesLead product and process risk management activitiesInvestigate and prevent nonconformances (NCRs); develop rework proceduresLead CAPA system activities and verify effectivenessTrack and report quality KPIs to QRB; participate in CRB meetingsReview calibration OOTAs and support remedial actionsManage change control for quality documentation and risk managementProvide SME guidance on quality documentation and product/process changesSupport document controls and write/improve procedures, forms, and instructionsPrepare and execute TMV documentation; support process improvements and development projectsAssist with complaint investigations and internal auditing; support external auditsMentor less experienced staff and perform other duties as assignedLead in standardizing quality practices within one critical QMS area (e.g., CAPA, NCR)Facilitate CRB, QRB, and Management Review meetingsTrend data and prepare for Management Reviews; participate in management discussionsLead and perform data-driven analysis for sampling and process improvementsWrite and execute Test Method Validation (TMV) documentation as neededBe part of the internal auditing team as a certified auditor\nKey requirementsExperience with ISO 13485 and/or 21 CFR Part 820Willingness to travel up to ~5%Strong attention to detail and organizational skillsProficiency in analytical and problem-solving techniquesEffective communication and teamwork in fast-paced environmentsStrong technical writing skillsProficiency with Microsoft Office (Word, Excel, PowerPoint)English literacy (read/write)Auditor or Lead Auditor certification (preferred)Experience with EU MDR 2017/745 (preferred)Experience with ISO 14971 (preferred)attention to detailorganizational skillsclear communicationISO 1348521 CFR Part 820FMEA","company":"Ambu","rawCompany":"ambu","city":"Carmel","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-09-15T03:43:46.603Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Overview\nIn this role you support R&D and Process Engineering to ensure design controls and risk management are integrated into product development. You will help maintain and improve the QMS to meet regulatory requirements and internal practices. You address quality issues and drive risk-based decisions across design, manufacturing, and verification activities. Your work focuses on patient safety, compliance, and delivering high-quality medical devices.\n\nResponsibilitiesIdentify and implement QC systems to support manufacturing and product developmentImprove and streamline quality practices to resolve issuesApply systematic problem-solving to prioritize and resolve quality issuesLead product and process risk management activitiesInvestigate and prevent nonconformances (NCRs); develop rework proceduresLead CAPA system activities and verify effectivenessTrack and report quality KPIs to QRB; participate in CRB meetingsReview calibration OOTAs and support remedial actionsManage change control for quality documentation and risk managementProvide SME guidance on quality documentation and product/process changesSupport document controls and write/improve procedures, forms, and instructionsPrepare and execute TMV documentation; support process improvements and development projectsAssist with complaint investigations and internal auditing; support external auditsMentor less experienced staff and perform other duties as assignedLead in standardizing quality practices within one critical QMS area (e.g., CAPA, NCR)Facilitate CRB, QRB, and Management Review meetingsTrend data and prepare for Management Reviews; participate in management discussionsLead and perform data-driven analysis for sampling and process improvementsWrite and execute Test Method Validation (TMV) documentation as neededBe part of the internal auditing team as a certified auditor\nKey requirementsExperience with ISO 13485 and/or 21 CFR Part 820Willingness to travel up to ~5%Strong attention to detail and organizational skillsProficiency in analytical and problem-solving techniquesEffective communication and teamwork in fast-paced environmentsStrong technical writing skillsProficiency with Microsoft Office (Word, Excel, PowerPoint)English literacy (read/write)Auditor or Lead Auditor certification (preferred)Experience with EU MDR 2017/745 (preferred)Experience with ISO 14971 (preferred)attention to detailorganizational skillsclear communicationISO 1348521 CFR Part 820FMEA","datePosted":"2026-09-15T03:43:46.603Z","dateModified":"2026-09-15T03:43:46.603Z","hiringOrganization":{"@type":"Organization","name":"Ambu","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Carmel","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"a4e4287bd7f21885936fc4a9"},"url":"https://jobsearcher.com/jobs/a4e4287bd7f21885936fc4a9"}}