Medical Device Risk & Quality Lead (Software Focus)
Axoft
Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own Axoft’s organizational risk management system across product design, development processes, and software. The immediate priority is software risk, with broader risk management support as the device and quality system mature. The role requires hands-on FMEA or structured risk assessment experience in regulated industries, familiarity with ISO 14971, and capability to engage with engineers while maintaining #J-18808-Ljbffr Axoft
- ...pharmaceutical, biotechnology, and medical device safety and efficacy... ...Keeping equipment/software function process.... .... Guarantee top quality of services provided to... ...compliance and safety focused. Strong operational... ...exposed to fumes and the risk of electrical shock,...QualitySoftwareRiskMedical deviceContract workRotating shift
$50k
...primary areas of focus for this role include... ...and ensure quality execution of services... ...Mission - to be the leading provider of automation... ...pharmaceutical or medical device validation ~5+... ...00 ~ ISO 14971 – risk management for... ...equipment and associated software systems...QualitySoftwareRiskMedical deviceTemporary workFor contractorsWork experience placementWork at officeWeekend work$155k - $185k
...scale the execution of our Software as a Medical Device programs. This role will partner... ....This is an execution-focused role for someone who has experience... ...Clinical, Regulatory, and Quality to plan and deliver against... ...and identifying risks earlySupport development in...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation- ...seeking a Design, Process, and Software Quality Risk Specialist to own risk... ...processes, and software. The initial focus is software risk, with the role expanding as the device and quality system mature.... ...is a plus as we apply it to medical device safety. #J-18808-Ljbffr...QualitySoftwareRiskMedical device
$120k - $160k
...market access activities for Software as a Medical Device (SaMD), wearable... ...health products. This role focuses primarily on international... ...communicate regulatory impacts, risks, timelines, and submission... ...Provide occasional support for Quality Management System activities...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$88.6k - $246.6k
...Solution Implementation Lead is the end‑to‑end... ...operationalization of new connected medical device and digital health... ..., with a primary focus on the respiratory service... ...milestones, dependencies, risks, constraints, and... ...Solution‑Level Readiness, Quality & ComplianceEnsure solution...QualityRiskMedical deviceFull timePart timeImmediate startRemote workWorldwide$170k - $230k
...work: building and leading the engineering... ...across regulatory, quality, clinical science, product, software, and firmware to deliver... ...a regulated medical device development environment... ...rigorOwn the risk posture for your function... ...keeping the team focused on the highest-...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation- ...seeking a System Engineer focused on hardware development.... ...hardware, and drive risk management for EEG and cardiopulmonary device systems in a regulated environment... ...hardware, firmware, software, and product teams, and... ...manufacturers, ensuring quality and regulatory...QualitySoftwareRiskMedical deviceContract work
- ...Trenchless Geotechnical Team Lead will report to the... ...-to-day tasks include:Focus on leading and executing... ...OpenGround and/or gINT software, which will also... ...Perform data management and quality control of geological data... ..., scheduling and risk management for all geological...QualitySoftwareRiskFor contractorsLocal areaRemote work
$210k - $230k
...Clinical Operations, you will lead the clinical operations... ..., with a particular focus on Software as a Medical Device (SaMD). You will own operational... ...studies, ensuring high-quality, efficient, and compliant... ...study progress, operational risks, resource needs, vendor performance...QualitySoftwareRiskMedical deviceFull timeWork at officeRemote workRelocation$114k - $182k
...solutions and systems with focus on complex distributed software solutions. You’ll... ...to deliver world leading, cutting-edge... ...Clinical Engineering, and Risk Management teams to... ....Drive SW FMEA for medical device software and... ...has access to the quality healthcare that we...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$238k - $374k
...to patients. By focusing R&D efforts on... ...Regulatory Affairs CMC Devices and Drug-Device... ...strategies for medical devices and... ...product, quality, clinical, development... ...contribute:Leads and develops a... ...human factors, risk management, and... ...biocompatibility, software and...QualitySoftwareRiskMedical deviceMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$160k - $190k
...comes from a specific focus in these rapidly... ...to innovation and quality. We’re passionate... ...II and Class III medical device programs. The role... ...requirement management, risk management,... ...Essential Functions: Lead design inputs and... ..., Electrical, Software, Quality, Regulatory...QualitySoftwareRiskMedical deviceWorldwide$190k
...Advantage (TDA) practice focuses on helping clients... ...Application and Risk functions. We... ...transforming strategies into leading-edge tech... ...and shape high-quality technical solutions... ...of experience in software engineering, data... ...the full cost of medical, dental, and vision...QualitySoftwareRiskWork at officeLocal area$145k - $165k
...and influencer marketing software, services, and data, trusted by leading brands and agencies worldwide... ...strategy with a deep focus on the Boston market, informed... ...prioritize candidate quality, speed, and experience... ...Centric: You anticipate risks and opportunities, connect...QualitySoftwareRiskPermanent employmentFull timeLocal areaRemote workWorldwide- ...Qualio is a unified quality and compliance management... ...faster with reduced risk. Trusted by biopharma,... ...all work is customer-focused. What skills do I need... ...-related role for a medical device or life sciences company... ...project management software Exceptional organizational...QualitySoftwareRiskMedical deviceTemporary workRemote workWorldwideHome officeFlexible hours
- ...electromechanical devices. This includes... ...Key Skills Medical Device... ...Statistical Analysis Software, Vendor Management... ...devices, focusing on capital and/... ...partners by analyzing quality, cost, delivery... ...providers. Lead and collaborate... ...manufacturing risk assessment and...QualitySoftwareRiskMedical deviceContract workWork at office
$160k - $190k
...Quality Leader Quality is how Lumafield earns... ...hardware manufacturing, software, cloud services,... ...demand. This can include leading our efforts in achieving... ...the primary industry focus is medical devices. You will act as a... ...and mitigate risks. About you:...QualitySoftwareRiskMedical deviceFull timeFlexible hours$118.3k - $207.4k
...Our portfolio offers software tools coupled with content... ..., with a particular focus on the healthcare... ...regulatory exposures and risks related to (i) development... ...but not limited to medical device regulations applicable... ...drive effective, high-quality legal services. You're...QualitySoftwareRiskMedical deviceFull timeWork at office$137k - $235.75k
...Function: R&D Software/Systems EngineeringJob... ...Manager leads a team of multidisciplinary... ...‑critical medical navigation... ...regulatory and quality system... ...of system-level risk management, requirements... ...medical device environment.· Lead... ...with particular focus on navigation system...QualitySoftwareRiskMedical deviceFull timeImmediate start$92k - $148.35k
...DevelopmentJob Sub Function: R&D Software/Systems EngineeringJob... ...regulatory and quality system requirements.... ...requirements, and risk controls. This role requires... ...plans for complex medical devices, including system verification... ...Behavior, Execution Focus, Model-Based Systems...QualitySoftwareRiskMedical deviceFull timeWork at officeLocal areaImmediate start3 days per week$140k - $175k
...most advanced hardware, software, and AI technology to... ...team: fast, focused, and motivated by impact... ...regulatory requirements for medical devices, and you'll have a track... ...targets, and data quality.Manage clinical data operations... ..., budgets, and risk mitigation plans. Flag...QualitySoftwareRiskMedical deviceFull timeContract workImmediate startWorldwideNight shift$137k - $236k
...assigned. This position will support software enabled medical devices with focus on major markets including the... ...in key activities including Quality Management Reviews, risk management, design reviews,... ...authorities/development partners and lead/enable strong cross-functional...QualitySoftwareRiskMedical deviceWork visa- ...documentation for combination drug-device and biologic products,... ..., EU MDR, and internal quality standards throughout... ...activities. Perform risk management activities,... ...in a regulated medical device or combination product... ...JAMA and Windchill software Ability to work independently...QualitySoftwareRiskMedical device
$200k - $250k
...advanced hardware, software, and AI technology... ...team: fast, focused, and motivated by... ...requirements for medical devices, and you'll have a... ...to ensure trials lead to successful clearance... ...targets, and data quality.Manage clinical data... ...timelines, budgets, and risk mitigation plans....QualitySoftwareRiskMedical deviceFull timeContract workImmediate startWorldwideNight shift$192k - $288k
...infrastructure, FinOps, build systems, software migrations, security... ...know what's on track, what's at risk, and what decisions are needed... ...and what improves, not by the quality of your tracking. Preferred... ...collaborative teammates who stay focused on our north star: delighting...QualitySoftwareRisk- ...pharmaceutical, biotechnology, and medical device safety and efficacy... ...to a safe and quality working environment... ...monthly Inspection. (e-tool software) related with... ...the ability to adjust focus. He / she may frequently... ...exposed to fumes and the risk of electrical shock,...QualitySoftwareRiskMedical deviceLocal area
$115k - $225k
...STANLEYMorgan Stanley is a leading global financial... ...build portfolios focused on what is... ...tradeoffs, and surfacing risks, dependencies, and... ....Improve solution quality and business... ...Agile/Lean/Kanban software development processesAdvanced... ..., including Medical, Prescription Drug...QualitySoftwareRiskTemporary workWork at officeLocal areaRemote workWorldwide3 days per week$175k - $225k
...growing, Boston-based medical technology company... ...care - leading to better patient... ...outcomes, improved quality of care, and reduced... ...experience in the medical device industry and 2-5+... ...guiding software development lifecycle... ...including audits, CAPA, risk management and...QualitySoftwareRiskMedical deviceWork at officeLocal area$102k - $163k
...Job Title Software Design Assurance Quality Engineer Job Description... ...of cloud based medical software used to... ...Your role: Leads the assessment of... ...quality plans and risk management... ...regulated medical device/Tech software environments... ...4/82304), with a focus on Software...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week
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