Medical Device QA
731 open positions
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Sr Quality Assurance Specialist↗ GrifolsSan Diego, CA, US $108k–$108k1mo Manages nonconformances, Out-of-Tolerance Reports, and CAPA records to ensure timely corrective actions and comprehensive documentation for nucleic acid testing instruments.
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Quality Engineer II NordsonhcmUSA - New Hampshire - Salem 1mo Ensure manufacturing operations comply with Good Manufacturing Practices (GMP) and FDA/ISO standards for medical devices.
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Quality Assurance Lead- 4th Shift BdxUSA TX - El Paso - Northwestern Dr. 1mo Lead in-process quality inspections, audits, and testing for medical device manufacturing to ensure compliance with GMP and product specifications.
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Senior Quality and Compliance Manager↗ Meditrial EuropeMinneapolis, MN, US 1mo Manage Quality and Compliance activities for GCP/GVP and FDA BIMO Compliance, maintain ISO certifications, and ensure compliance across clinical projects.
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Quality Engineer↗ W. L. Gore & AssociatesFlagstaff, AZ, US 1mo Design Assurance/Product Quality Engineer supporting new medical device development by defining requirements, managing risks, and executing verification/validation.
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Document Control and QARA Executive (MEDICAL DEVICE)↗ Merlin Md Pte. Ltd.Yishun, S00, SG 1mo Lead the execution and continuous improvement of the Quality Management System and quality assurance activities to ensure regulatory compliance and support product excellence for medical devices.
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Senior Quality Assurance Engineer I MeritSouth Jordan, UT 2mo Conducts complex quality engineering work for specific medical device product lines, focusing on failure investigation, risk analysis, supplier quality, and validation protocols.
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Sr. Quality Engineer↗ Intuitive (intuitive Surgical)Mexicali, BCN, MX 2mo Executes and maintains advanced QA systems, leads complex investigations and validations, and ensures compliance with internal, regulatory, and industry standards for robotic-assisted surgery devices.
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Directeur Qualité France F/H BrenntagGenas,France 2mo Define and deploy the Quality strategy for France, manage the Quality team, and drive continuous improvement in Life Sciences distribution.
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Senior Quality Systems Engineer↗ RxsightAliso Viejo, CA, US 2mo Own the day-to-day operation of the Nonconforming Material Report (NCMR) and Material Review Board (MRB) program, coordinating investigations, dispositions, and closure activities across Manufacturing, Engineering, Supply Chain, and Regulatory Affairs.
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Lead Auditor, Quality Compliance↗ Integra LifesciencesTullamore, County Offaly, Ireland 2mo Lead corporate audits of the Quality Management System (QMS) across global medical device design, manufacturing, and distribution facilities to ensure compliance with regulatory standards and internal policies.
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Quality Assurance Manager↗ North American Production SharingTijuana, BCN, MX 2mo Leading and overseeing all Quality Assurance activities within a manufacturing facility to ensure regulatory compliance and quality standards for medical devices.
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Quality Site Head BaxterAibonito, Puerto Rico $168k–$168k2mo Lead the Quality Management System (QMS) for a manufacturing plant, ensuring regulatory compliance and product safety.
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Quality Engineer↗ Omega PlasticsClinton Township, MI, US 2mo Ensures compliance and quality assurance for medical device components through validation programs, risk assessments, and process control.
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Quality Engineer↗ TriMas CorporationClinton Township, MI, US 2mo Ensures compliance and quality assurance for medical device components through validation programs, risk assessments, and process control.
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Advanced Engineer DQA MedlineShanghai 上海 2mo Own project management and product development testing strategies to minimize failures during new product introduction (NPI) for medical devices.
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Senior Director Quality↗ Laborie Medical TechnologiesPortsmouth, NH, US 2mo Develop, implement, and continuously improve Product Quality and Production Quality programs across the medical device lifecycle to ensure regulatory compliance and patient safety.
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QA Compliance Supervisor↗ Balda C BrewerOntario, CA, US 2mo Supervise QA staff and document control to ensure compliance with FDA, GMP, and ISO 13485 standards.
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Quality Program Manager MedtronicHerzliya, Tel Aviv, Israel 2mo Integrating CathWorks quality systems and processes into Medtronic's global quality framework to ensure regulatory compliance and process harmonization.
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Principal Software Design Engineer (Medical)↗ RN Care Pte. Ltd.Bugis, S00, SG 2mo Establishing risk management processes and maintaining ISO 13485 and IEC 62304 compliant quality management systems for medical device projects.
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QA Engineer Digitial Systems DexcomAthenry, Ireland 2mo Ensuring quality of site processes and digital manufacturing to Dexcom standards, supporting the product life cycle.
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QA Engineer Digitial Systems↗ Dexcom Ireland - AthenryAthenry, County Galway, Ireland $50k–$50k2mo Ensuring quality of site processes and digital manufacturing to Dexcom standards, supporting compliance and validation of manufacturing and digital systems.
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Non Product Software Validation Engineer PhilipsBangalore 2mo Ensures product quality and regulatory compliance by implementing validation procedures, managing recalls, and overseeing supplier quality processes for manufactured products.
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Quality Engineer (Complaint Handling) - Duncan, SC DanaherDuncan, South Carolina, United States 2mo Manage product failure/non-conformance, CAPA, and complaint processes while driving quality adherence and risk assessment in high-volume manufacturing.
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Engineer IV/Complaint Analysts TakedaLexington, MA $104k–$104k2mo Analyze and investigate customer complaints and returned medical devices to ensure quality, safety, and regulatory compliance.
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Senior Advanced Quality Engineer StrykerCork, Ireland 2mo Lead Quality Engineering activities to ensure product and process quality for new product development, providing guidance on compliance to quality systems and external standards.
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Lead/Senior QA Engineer, Quality Management System (QMS)↗ Biobot Surgical Pte. Ltd.Clementi, S00, SG 2mo Maintain and improve the Quality Management System (QMS) to ensure compliance with ISO 13485, EU MDR, MDSAP, and FDA QMSR requirements for medical devices.
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Quality Engineer IntuitiveParvomay, BULGARIA, bg 2mo Define quality metrics and specifications, lead quality improvement initiatives, and act as a technical consultant for complex robotics and optics quality challenges.
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Quality Assurance Compliance Specialist I ZollRemote $60k–$60k2mo Support the Quality Assurance Compliance team in maintaining global regulatory compliance and the Quality Management System (QMS) for medical devices.
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Quality Management System SailPointPune, India 2mo Central owner of QMS policies, procedures, and records ensuring audit readiness for multi-framework compliance (SOC 2, ISO, FedRAMP, GxP) and serving as the named quality representative for life-sciences customers.
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Senior Vigilance Specialist↗ CepheidSolna, Stockholm County, Sweden 2mo Developing vigilance activities including Adverse Event Reporting and Field Action coordination to ensure regulatory compliance for medical diagnostic systems.
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Director, Quality↗ Integer Holdings CorporationNew Ross, Ireland 2mo Provide strategic quality leadership to manufacturing sites, ensuring compliance with regulatory standards and driving a culture of quality for medical device OEMs.
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Supervisor Design Assurance (m/f/d) NovantaBerlin, Germany 2mo Lead the local Design Assurance team in Berlin while actively contributing as a Design Assurance Engineer to ensure product quality and regulatory compliance for medical devices.
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Senior Quality Engineer↗ SterisBishop's Stortford, England, UK 2mo Senior Quality Engineer supporting new product development, complaint/CAPA processes, and Quality Management Systems for ultrasonic and sonic irrigators.
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Quality Engineer↗ Smith+nephewKingston Upon Hull, England, UK 2mo Ensure quality of life-changing medical devices through statistical process control, root cause analysis, and continuous improvement in manufacturing.
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Sr. Associate Quality Systems Specialist McKessonCork $40k–$40k2mo Senior Quality Systems Specialist ensuring compliance with medical device regulations and international quality standards by managing the Quality Management System (QMS), processing customer complaints, and supporting audits.
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Quality & Regulatory Leadership Program GehcWaukesha, US 2mo A rotational development program for recent graduates to gain experience in Quality Assurance and Regulatory Affairs across GE HealthCare's business units.
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Quality Engineering Manager↗ EmbectaCounty Dublin, Ireland 2mo Leading quality engineering, validation, and quality control functions to ensure product quality, process improvement, and regulatory compliance in medical device manufacturing.
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Quality Specialist GlobusmedicalMethuen, MA 2mo Ensuring compliance with US FDA, international medical device regulations, and ISO 13485 quality system requirements while managing manufacturing quality and the quality management system.
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