Global Device Risk & Post-Market Quality Engineer
BioSpace
Sanofi Inc. in Cambridge, MA is seeking a Device Quality Engineer to lead risk management, clinical evaluation, and post-market surveillance across the global device portfolio. You will ensure compliance with ISO 14971, MDR, and related regulatory requirements throughout the product lifecycle. You will partner with quality, compliance, development, and manufacturing teams to deliver expert evaluations, drive improvements, and mentor colleagues in risk management methodologies while supporting #J-18808-Ljbffr BioSpace
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Device Risk & Post-Market Quality Engineer in Cambridge, MA vacancy
- 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...Risk
- Job Title : Device Quality Engineer - Device Risk Management and Surveillance Excellence Location: Cambridge... ...Surveillance Excellence within our Global Device and Packaging Unit (GDPU), you... ..., Clinical Evaluation, and Post-Market Surveillance processes, ensuring Medical...RiskWorldwide
$170k - $267.5k
...Who we are looking forThe Global Head of Market Surveillance Compliance is a senior leadership role... ...ensure the surveillance program is robust, risk-based, technology-enabled, and aligned... ...processes to ensure consistency, quality, and defensible regulatory outcomes.Establish...RiskFull timeTemporary workFlexible hours- ...seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities... ...portfolio. You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN... ...Legal, Program Management, Quality, and overseas...RiskOverseas
$92.2k - $141.4k
...SharkNinja is a global product design... ...innovation to market and developing... ...Safety & Compliance Engineer will have a... ...employ appropriate risk mitigation... ...participation in medical device regulatory... ...to post-market surveillance... ...DevicesISO 13485 - Quality Management SystemsIEC...RiskTemporary workLocal areaFlexible hoursShift work$150k - $235k
...is a great opportunity to join our Middle Market team in Boston! This job is responsible... ...the largest commercial banks in the U.S., Global Commercial Banking (GCB) provides financial... ...of valuable financial solutions with the Risk & Compliance framework• Designs and...RiskFull timeWork experience placementWork at officeLocal areaFlexible hoursShift workDay shift$120.8k - $181.2k
...start here. Medtronic is a global leader in healthcare... ...and experienced Principal Risk Management Quality Engineer to join our innovative team... ...compliance within the medical device industry. This position requires... ...and managing post-market surveillance plans to monitor...RiskFull timeH1bWork at officeLocal areaImmediate startFlexible hours$87.8k - $150k
...SharkNinja is a global product design and... ...disruptive innovation to market and developing... ...Senior Medical Device Compliance Engineer Needham, MA,... ...design control, and post-market compliance... ...Management, and Quality Engineering, including... ...design reviews, risk management files,...RiskContract workTemporary workLocal areaOverseasFlexible hours$238k - $374k
...Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device... ...product, quality, clinical, development... ..., Supply Chain, Market Access, and... .../human factors, risk management, and... ..., labeling/UDI, post-market signals).... ...scientific, or engineering discipline (e.g....RiskMinimum wageTemporary workWork at officeLocal areaRemote workWorldwide$120k - $160k
...WHOOP is hiring an NPI Quality Engineer, Accessories to help... ...Operations, Deployment, Global Support Services, and... ...drive quality planning, risk management, validation... .../fitness, medical device, or high-tech industriesExperience... ...to reflect evolving market conditions and...RiskFull timeWork at officeRelocation$94.6k - $141.8k
..., GMP Operational Quality Assurance is a Quality... ...Biologics and Devices Quality Team, influencing... ...managing risk, and providing timely... ..., including global GMP manufacturing... ...job at the time of posting. This role is eligible... ...include inclusive market-leading benefits to...RiskFull timeContract workSummer workRemote workFlexible hours2 days per week$237.2k - $372.79k
...empower you to shine? Join us as a Global Medical Lead, Dermatology in... ...through our R&D-driven market leadership and being a values-... ...health applications, and wearable devices, to enhance patient care and engagement... ...of the dermatology portfolio. Risk Management: Ability to...RiskMinimum wageTemporary workWork at officeLocal areaRemote workWeekend work- ...is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices... ..., Program Management and Quality to ensure safe, compliant products... ...development. You will apply risk management, perform DFMEA,...RiskOverseas
$107.5k - $204.5k
...1857109Posted: Posted 27 Days AgoStart... ...With our three market leading... ...experience and renowned engineering expertise to... ...Software Systems Quality Engineer (... ...programs include Global Patriot, Ghost-... ...evaluations and risk assessments across... ...between devices and systems.Connectivity...RiskTemporary workWork experience placementWork at officeLocal areaImmediate startRemote workRelocationMonday to FridayFlexible hours- ...an experienced Senior Design Quality Engineer to support development of complex... ...leads Design Controls , risk management, and V&V quality... ...ISO 13485 , MDR/MDD , and global regulations. Lead risk management... ...Quality within medical devices (Class III preferred). ~ Strong...RiskFull time
VIR Healthway
Newton, MA1 day ago $115k - $182k
...Title Software Test Engineer - Medical Device Integration (Bedford,... ...implements effective risk control measures.... ...testable. Supports high-quality delivery by... ...experience collaborating with global software development... ...may vary within the posted ranges depending on multiple...RiskFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
Bedford, MAmore than 2 months ago- State Street is seeking a Global Head of Market Surveillance Compliance to design and oversee a comprehensive, risk-based surveillance program across trades and electronic communications. You will provide strategic leadership, independent oversight, and governance to ensure...Risk
$102k - $163k
...Software Design Assurance Quality Engineer Job Description... ...software quality plans and risk management activities, utilizes post-market analytics to monitor... ...knowledge of relevant global regulations, requirements... ...FDA regulated medical device/Tech software environments...RiskFull timeWork at officeImmediate startWork visaRelocation package3 days per weekPhilips
Cambridge, MAmore than 2 months ago$133.2k - $235k
...leading product experts supporting Global Transaction Services in client... ...relationship teams to package marketing leading solutions that address... ....Effectively manages risk while balancing the needs of the... ...does not make you ineligible to post.Shift:1st shift (United States...RiskFull timeWork experience placementWork at officeWork from homeFlexible hoursShift workDay shift- ...Description: The Product Design Quality Engineer is responsible for supporting... ...into product development, risk management, validation, and... ...Design History Files (DHF), Device Master Records (DMR), and related... .... Experience working with global engineering, regulatory, and...Risk
$150k
...expertly crafted Commercial Insurance and Risk Management, Private Insurance and Risk... ...channels and leading the expansion into new markets.Hire, manage, and provide coaching and... ...of Microsoft Office products and mobile device platforms and intermediate Excel skillsMust...RiskFull timeContract workWork at office$175k
...exchange offering is a cornerstone of our global product range, connecting markets directly with counterparts,... ...experienceExperience with automated pricing and risk management for principal electronic... .... We appreciate the unique qualities each candidate brings, and look...RiskFull timeTemporary workWorldwideFlexible hours- ...Job Description: The Design Quality Engineer will support the Lifecycle Management... ...existing medical device products across sports medicine... ..., regulatory affairs, marketing, R&D, and quality teams to support... ...process changes, perform risk management activities, execute...RiskRemote work
$206.25k - $297.92k
Job title: Global Market Access & Pricing Lead, Early NeurologyLocation: Cambridge, MA / Morristown... ...proposition, access opportunities, risks, and mitigation strategiesPlay a key role... ...and wellbeing benefits including high-quality healthcare, prevention and wellness programs...RiskFull timeWork at officeLocal areaWorldwide3 days per week$103k - $145k
Job TitleSenior Design Quality EngineerJob... ...hardware quality and safety risk management throughout... ...life cycle.A Quality Engineer provides independent oversight... ...performance and post‐market product quality analysisYou... ...with Medical Device experience. 5+ years of...RiskFull timeWork at officeImmediate startRemote workWork visaRelocation package3 days per week$175k
Who We Are Looking ForState Street Global Markets is seeking a highly motivated Assistant Vice... ...closely with FX traders to deliver high-quality execution and client service.Develop and... ...investors rely on us to help them manage risk, respond to challenges, and drive performance...RiskFull timeTemporary workWork at officeFlexible hours$212k - $333.19k
...industry through our R&D-driven market leadership and being a values-... ...changing work. Certified as a Global Top Employer, we offer... ...challenges assumptions, surfaces risks and tradeoffs, and positions market... ..., vendor briefs, analytical quality, and executive level insight storytelling...RiskMinimum wageTemporary workLocal areaImmediate startRemote work$154.4k - $242.55k
...brighter future for the world. As a global, values-based... ...Head of Global Insurance and Risk Management to support the development... ...submissions and support any market presentations.Proactively manage... ...activitiesSupport Risk Engineering Program - actively working with...RiskMinimum wageContract workTemporary workWork at officeLocal areaImmediate start- ...At Capgemini Engineering, the world leader in engineering... ...we bring together a global team of engineers,... ...a Senior Design Quality Engineer- Medical Devices. You will be responsible... ...to design controls, risk management, and SDLC... ...and post‑market activities. Your...RiskPermanent employmentFull timeLocal areaRemote work
$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility in Allston next year)Schedule: Onsite 5 days/week with... ...management, design reviews, and DV&V efforts Participate in Risk Management activities, including FMEA and hazard...RiskRelocation
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Device Risk & Post-Market Quality Engineer. Be the first to apply!
Related searches
- quality engineer Cambridge, MA
- quality systems engineer Cambridge, MA
- senior data quality engineer Cambridge, MA
- senior manager quality engineering Cambridge, MA
- customer quality engineer Cambridge, MA
- program quality engineer Cambridge, MA
- supplier quality engineer Cambridge, MA
- technology risk Cambridge, MA
- risk adjustment Cambridge, MA
- risk intern Cambridge, MA