Medical Device Risk & Quality Systems Specialist
Axoft
Axoft is building a new class of implantable neural interface with a software stack spanning firmware, embedded configuration tools, clinical monitoring apps, and cloud infrastructure. The Design, Process, and Software Quality Risk Specialist will own the organizational risk management system across design, development processes, and software, with software risk as the immediate priority. The ideal candidate has hands-on experience with FMEA or structured risk assessment in regulated industries, #J-18808-Ljbffr Axoft
$175k - $225k
...growing, Boston-based medical technology company using... ...patient outcomes, improved quality of care, and reduced... ...shape the team and the system. As our Director of... ...experience in the medical device industry and 2-5+ years... ...including audits, CAPA, risk management and post-...RiskMedical deviceWork at officeLocal area- ...technical team building compliant medical device systems the right way: risk-driven, Agile, and grounded in the... ...that govern product development, quality systems, and medical device software... ..., and Software Quality Risk Specialist to help own Axoft’s organizational...RiskMedical deviceImmediate startFlexible hours
$128.75k - $163.08k
...serious retinal diseases.The IT System and Validation Analyst is... ...Manufacturing Operations, Facilities, Quality Control, Quality Assurance,... ...Specifications (FS)Risk AssessmentsTraceability MatricesIQ... ..., biotechnology, medical device, or similar).EyePoint is committed...RiskMedical device$90.1k - $153.3k
...Job DetailsThe Principal Systems Test Engineer, R&D,... ...development of innovative medical technology products and... ...with engineering, quality, and product teams to deliver... ...&V for complex medical device, hardware, software,... ...robust test methods using risk-based, statistical, and...RiskMedical deviceHourly payFull timeTemporary workMonday to FridayFlexible hours$114k - $182k
...DescriptionSystems EngineerThe Systems Engineer will help define and... ..., Clinical Engineering, and Risk Management teams to provide... ...requirements.Drive SW FMEA for medical device software and solutions that... ...everywhere has access to the quality healthcare that we all deserve...RiskMedical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$95k - $145k
...compliance activities for complex GxP systems as a Senior Consultant, Regulatory, Risk, and Compliance. This role... ...skillsMeticulous attention to detail and quality of work productAbility to build... ..., including pharma, biotech, medical device, or clinicalExperience leading validation...RiskMedical deviceRemote workVisa sponsorship$138.4k - $190k
...System Integration Engineer R&D Research & Development – Cambridge, Massachusetts,... ...technical leads to identify project and system risks and develop recommendations and... ...environments such as automotive, aerospace, medical devices, or life-science tools is considered a plus...RiskMedical device- ...and III coagulation programs. You will own design controls, product reliability, and lead a five-person systems engineering team across requirements management, risk management, and V&V, with FDA submissions in mind. This hands-on leadership role combines technical authority...RiskMedical device
$157.08k - $227.46k
About Analog DevicesAnalog Devices, Inc. (NASDAQ: ADI) is a global semiconductor... ...AI Group (DAG) is hiring a System Engineer to own the project at... .../ PVT), and translate failure risk into design and test... ...product backgrounds (automotive, medical device, consumer electronics)...RiskMedical devicePermanent employmentFull timeContract workWork at officeDay shift$65k - $85k
...Job Title: Quality Associate Department: Quality and... ...Sr. Quality Engineer, Device Operations, Sustaining... ...complications in high-risk populations. We are a mission... ...data, formal quality system documentation, and... ...years of experience in the medical device industry, with...RiskMedical deviceTemporary workWork at officeRemote workFlexible hours- ...You will guide requirements management, risk management, V&V, and traceability from design... ...to output. This hands-on leader will set system integration strategies, develop plans and... ...with Mechanical, Electrical, Software, Quality, Regulatory, and PM teams while mentoring...RiskMedical device
- ...across multiple projects. You will manage a five-person systems engineering team, guide requirements management, risk assessment, and system integration, while partnering with Mechanical, Electrical, Software, Quality, Regulatory, and PM groups. #J-18808-Ljbffr Socket....RiskMedical device
$111k - $185k
...Summary of role The Supplier Quality Senior Specialist is responsible for... ...SQM) program, ensuring that systems, processes and procedures between... ...audit planning, including risk-based execution and... ...Pharmaceutical, Biotech and /or Medical Device industry, or equivalent combination...RiskMedical deviceContract workFor contractorsLocal areaRemote work- ...reliability, and a five-person systems engineering team, while guiding requirements, risk, and verification from design input... ...The role requires FDA-regulated device experience, a strong leadership... ..., electrical, software, quality, regulatory, and project management...RiskMedical device
- ...software-tunable drug-delivery system designed to support high-... ...companies and key players in the medical device ecosystem to integrate our... ...functionally with engineering, quality, regulatory, manufacturing,... ...lifecycle management • Support Risk Management documentation (RMF...RiskMedical deviceTemporary workCasual workWork at officeFlexible hours
$50 - $55 per hour
...(SGA), is searching for a Quality Assurance Specialist for a contract assignment... ...control documents including risk analysis, IQ, OQ, URS and... ...Corrective And Preventive Action system, to ensure action, closure... ..., biotechnology, medical device, or diagnostic industries,...RiskMedical deviceFull timeContract workFor subcontractorCasual workShift work- ...andmaintainrobust logging, record, and playback systems to support debugging, verification, and... ..., andhardwareengineers Support risk analysis, design reviews, and root-cause... ..., Gentoo, etc.) Experience in the medical device industry, ideally with interventional or...RiskMedical deviceFor contractors
- ...Staff Software Systems Engineer Anywhere Type:... ...traceability, and software risk analysis for software-... ...package that includes Medical, Dental, and Vision benefits... ..., and maintain high-quality System and Software... ...specifications across device, app, cloud, backend, data...RiskMedical deviceHourly payContract workLocal areaRemote work
- ...motivated and experienced Senior System Engineer to join our R&D team... ..., firmware, mechanical, quality, and regulatory teams to ensure... ...regulatory teams * Support risk management activities, including... ...engineering within the medical device industry, with a focus on complex...RiskMedical deviceImmediate start
- MilliporeSigma in Burlington, MA seeks a Quality Assurance/Quality Management Systems professional to maintain and improve the local QMS in line with ISO 9... ...training, and CAPA execution. Responsibilities include risk management, audits, and coordinating internal and external...RiskLocal area
$148k - $170k
...Senior Systems EngineerCoreMap's mission is to improve... ...including software, hardware, quality, regulatory and... ...the Design History File, Device Master Record and... ...development (e.g., DFMEA, Risk Assessment, Design Reviews... ...and manufacturing of medical devices.Partner with QA...RiskMedical deviceFull timeContract workWork at office- ...Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves... ...FDA, ISO 13485, and internal quality system requirements. Experience... ...Support design verification, risk management, and product validation...RiskMedical device
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance... ...matter expert in GMP quality systems, CMC quality oversight,... ...Identify and communicate quality risks while partnering with... ...of pharmaceutical and medical device Quality Management Systems...RiskMedical deviceFull timeContract workImmediate start
$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new... ...&V efforts Participate in Risk Management activities,... ...with ISO 13485, FDA Quality System Regulations (21 CFR 820),... ...quality experience within medical devices, combination products...RiskMedical deviceRelocation- ...SkillsDesirable Skills:Skills: EIS: Medical Device & Regulations ~EIS: New... ...leadership experience· Design Quality Engineering experience· Design... ...strategy for area/site.· Performing risk management, execute product testing· Work on Quality System, including, but not limited to...RiskMedical deviceWork experience placement
$140k - $165k
...growing, Boston-based medical technology company using... ...patient outcomes, improved quality of care, and reduced... ...validation for major system enhancements and new product... ...validation, medical device regulation, and... ...complex projects, and make risk-based decisions to ensure...RiskMedical deviceWork at officeLocal areaRemote work$166k - $220k
...industry, Anduril is changing how military systems are designed, built and sold. Anduril’s... ..., strategic technical planning, risk management, and proposal efforts as neededREQUIRED... ...in robotics, autonomous systems, medical devices, or high-volume electromechanical productsDefense...RiskMedical deviceFull timeWork experience placementImmediate startShift work- ...plus; years of experience in medical device or regulated manufacturing environments... ...(TMV) and Computerized System Validation (CSV) in... ...establish traceability across risk controls, process parameters,... ...functional collaboration with Quality, Manufacturing Engineering, R...RiskMedical device
- ...Design Quality EngineerResponsible for ensuring compliance to design controls, risk management, and verification/validation activities across... ...the product lifecycle for medical devices, with a strong preference for ultrasound/imaging systems.Skill Requirement:Strong understanding...RiskMedical device
- ...documentation for combination drug-device and biologic products,... ..., EU MDR, and internal quality standards throughout... ...activities. Perform risk management activities,... ...management, quality systems, and risk management... ...experience in a regulated medical device or combination...RiskMedical device
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