Medical Device Software Risk & Quality Lead
Socket.dev
Axoft is seeking a Design, Process, and Software Quality Risk Specialist to own organizational risk management across product design, development processes, and software. The role prioritizes software risk but supports risk management across the organization as the device and quality system mature. Ideal candidates have hands-on experience with FMEA or structured risk assessment, some grounding in quality systems, and sufficient software literacy to engage engineers. #J-18808-Ljbffr Socket.dev
- ...System Validation (CSV) Lead to oversee validation... ...documentation, risk assessments, and cross... ...periodic reviews. Support software implementation, upgrades... ...validation activities with IT, Quality Assurance, Engineering... ..., biotechnology, medical device, or life sciences...QualitySoftwareRiskMedical device
- Werfen seeks a Senior Engineering Group Lead to own design controls and product reliability... ...You will guide requirements management, risk management, V&V, and traceability from... ..., and work with Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while...QualitySoftwareRiskMedical device
$50k
...to develop and ensure quality execution of services,... ...and Mission - to be the leading provider of automation... ...in pharmaceutical or medical device validation ~5+ years... ...-E2500 ~ ISO 14971 – risk management for medical... ...and associated software systems Holistic understanding...QualitySoftwareRiskMedical deviceTemporary workFor contractorsWork experience placementWork at officeWeekend work- ...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
$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- ...Design Quality EngineerResponsible for ensuring compliance to design controls, risk management, and verification/validation activities... ...the product lifecycle for medical devices, with a strong preference for... ...electrical safety)IEC 62304 (software lifecycle)IEC 62366 (...QualitySoftwareRiskMedical device
$140k - $165k
...growing, Boston-based medical technology company... ...care - leading to better patient... ...outcomes, improved quality of care, and reduced... ...cardiovascular imaging software. In this role, you... ...validation, medical device regulation, and... ...projects, and make risk-based decisions to...QualitySoftwareRiskMedical deviceWork at officeLocal areaRemote work- Sanofi seeks a Device Quality Engineer to lead risk management and post-market surveillance for medical devices and drug-device combinations. You will oversee global processes, ensure ISO 14971 compliance, and collaborate with cross-functional teams to safeguard patient...QualityRiskMedical device
$155k - $185k
...and help scale the execution of our Software as a Medical Device programs. This role will partner closely... ..., Clinical, Regulatory, and Quality to plan and deliver against program milestonesWork... ...key deliverables and identifying risks earlySupport development in...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation- ...is building a new class of implantable neural interface with a software stack spanning firmware, embedded configuration tools,... ..., and cloud infrastructure. The Design, Process, and Software Quality Risk Specialist will own the organizational risk management system...QualitySoftwareRiskMedical deviceImmediate start
$120k - $160k
...global market access activities for Software as a Medical Device (SaMD), wearable technologies, and digital... ...and communicate regulatory impacts, risks, timelines, and submission... ...stakeholders.Provide occasional support for Quality Management System activities, audits,...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$88.6k - $246.6k
The Solution Implementation Lead is the end‑to‑end execution owner... ...of new connected medical device and digital health solutions.... ...including milestones, dependencies, risks, constraints, and mitigation... ...issues. Solution‑Level Readiness, Quality & ComplianceEnsure solution‑...QualityRiskMedical deviceFull timePart timeImmediate startRemote workWorldwide- ...Team Lead To assist the Project Manager in ensuring successful monitoring... ...associated with a particular software lifecycle phase by guiding the assigned... ...manner Assist Project Manager in Risk Management and participate in quality reviews and implement quality norms...QualitySoftwareRisk
$150k - $210k
...addressing any issues related to data and data quality. Contribute to ongoing research efforts and explore... ...developing or supporting regulated or high-risk ML systems (e.g., digital health, software as a medical devices), including familiarity with validation, documentation...QualitySoftwareRiskMedical deviceFull timeWork experience placementWork at officeRelocation$170k - $230k
...that work: building and leading the engineering and science... ...across regulatory, quality, clinical science, product, software, and firmware to deliver... ...operate inside a regulated medical device development environment... ...regulatory rigorOwn the risk posture for your function...QualitySoftwareRiskMedical deviceFull timeWork at officeRelocation$90k - $165k
...responsible for testing and verification of software as a medical device, medical device systems and software... ...within schedule constraints, meeting quality standards and goals. Role... ...value in client engagements • Reviewing risk analysis and experience working on FMEA...QualitySoftwareRiskMedical device$95k - $145k
...Consultant, Regulatory, Risk, and Compliance. This... ...be responsible for… Lead end-to-end validation... ...attention to detail and quality of work productAbility... ...including pharma, biotech, medical device, or clinicalExperience... ...validating cloud or software as a service platforms...QualitySoftwareRiskMedical deviceRemote workVisa sponsorship- ...lifecycle management of Class II medical devices. Provide regulatory guidance... ...with Research & Development, Quality Assurance, Clinical,... ...regulatory input to design controls, risk management, change control,... ...MDR, Canada). Experience with software-enabled, electrical, or...QualitySoftwareRiskMedical device
- ...Trenchless Geotechnical Team Lead will report to the Trenchless... ...utilizing OpenGround and/or gINT software, which will also include... ...drawings.Perform data management and quality control of geological data.Aid... ...estimating, scheduling and risk management for all geological...QualitySoftwareRiskFor contractorsLocal areaRemote work
$116k - $182.27k
...The Manager, Planning Lead will attend clinical project... ...recommendations, and risk mitigation through... ...operations, and Quality Assurance.Interfaces with... ...Utilizes SmartSignals software to request packaging/labeling... ....Experience with Medical Devices a plus.Basic understanding...QualitySoftwareRiskMedical deviceMinimum wageContract workLocal area$136.86k - $195.51k
...diseases with high unmet medical need. Learn more at... ...afraid to take intelligent risks. People who act with... ...impact.Purpose & Scope The Lead, Upstream Marketing... ...partnerships to ensure high-quality execution of marketing... ...biotechnology, medical device, or healthcare...QualityRiskMedical deviceWork at officeRemote workWork from homeWorldwide$136.4k - $253.2k
...Data Science is recognized as a leading hub for top industry talent,... ...the delivery of high-quality, regulatory-compliant analytical... ...proactively addressing potential risks to support internal audits... ...promoting best practices in software development, analytics tooling...QualitySoftwareRiskFull timeLocal area- ...pharmaceutical, biotechnology, and medical device safety and efficacy... ...employee’s Time Keeping equipment/software function process.... ...timely manner. Guarantee top quality of services provided to client... ...be exposed to fumes and the risk of electrical shock, and occasionally...QualitySoftwareRiskMedical deviceContract workRotating shift
- ...Remote50% Remote Responsibilities: Lead and manage clinical data... ...project timelines, budgets, and quality standards. Provide strategic... ...familiarity with statistical software (e.g., SAS, R) is a plus. CCDM... ...certification. Experience with risk-based monitoring in oncology studies...QualitySoftwareRiskWork at officeRemote work
$90.1k - $153.3k
...development of innovative medical technology products... ...services. This role leads system-level... ...partners with engineering, quality, and product teams to... ...for complex medical device, hardware, software, interface, and integrated... ...test methods using risk-based, statistical,...QualitySoftwareRiskMedical deviceHourly payFull timeTemporary workMonday to FridayFlexible hours$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 execution... ...progress, operational risks, resource needs, vendor...QualitySoftwareRiskMedical deviceFull timeWork at officeRemote workRelocation- ...authoring/development of quality solutions that meet... ...how pharmaceutical and medical device companies use... ...solutions and articulate risks and benefits* Provide... ...experience with declarative software configuration* Proven... ...consulting company that leads with outcomes to bring...QualitySoftwareRiskMedical deviceLocal areaShift work
$128.75k - $163.08k
...1, and FDA's Computer Software Assurance (CSA) guidance... ..., Facilities, Quality Control, Quality Assurance... ...Functional Specifications (FS)Risk... ...resolution, etcAbility to lead and coordinate cross-functional... ...pharmaceutical, biotechnology, medical device, or similar).EyePoint...QualitySoftwareRiskMedical device- ...Manufacturing Engineer Medical DeviceThe Senior... ...for medical devices, ensuring robust and... ...emphasizes efficiency, quality, regulatory... ...validation, including risk assessments and... ...process validations.Lead or contribute to pFMEA... ...and statistical software like Minitab or...QualitySoftwareRiskMedical deviceContract workWork at office
$114k - $182k
...on complex distributed software solutions. You’ll work... ...team to deliver world leading, cutting-edge Patient... ...Clinical Engineering, and Risk Management teams to... ....Drive SW FMEA for medical device software and solutions... ...everywhere has access to the quality healthcare that we all...QualitySoftwareRiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week
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