Quality Systems Lead - AI, Cybersecurity & Medical Devices
Pro Staff
Pro Staff in Marlborough, MA is seeking a Quality Systems Process Lead to drive improvements in supplier controls, cybersecurity, and regulatory compliance for medical devices.
With 5+ years in Quality Systems and a strong grasp of FDA regulations, ISO 13485, and risk management, you will lead cross-functional teams, develop procedures, and ensure inspection readiness across the organization.
Hybrid work arrangement with 3 days onsite in Marlborough and comprehensive benefits are offered.
#J-18808-Ljbffr- ...in Boxborough, MA seeks a seasoned Imaging Systems Engineer to design, develop, and optimize imaging solutions for medical devices. You will drive end-to-end imaging pipelines... ..., and collaborate with marketing, quality, software, hardware, and test teams to meet...QualityMedical device
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...robotics and autonomous systems to medical devices, digital solutions,... ...Solutions Technical Lead to drive architecture... ...to elevate delivery quality QualificationsWhat You... .../computer vision, or AI/ML • Microservices, Docker... ...mobile development • Cybersecurity, secure deployments,...QualityMedical devicePermanent employmentWork at officeRelocation package$141k - $237k
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...security.Responsibilities:Lead and mature global cybersecurity operations across corporate... ...with Product Security, R&D, Quality, and Regulatory teams to support secure medical device development, threat modeling... ...monitors and desktop systems (~20 pounds).NOTE: This position...QualityMedical deviceFull timeWork at office$102.4k - $153.55k
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...flexibility) Industry: Medical Device DiagnosticsMust-Have... ...architectures.Linux Systems: In-depth understanding... ...technical team leads and driving platform-... ...Functional Leads.Technical Quality: Conduct rigorous... ...Plus)Experience with cybersecurity, threat modeling, or...QualityMedical deviceWorldwide- ...impact in fields as diverse as cybersecurity, healthcare, aviation,... ...expertise in mission engineering, systems integration, systems engineering... ...Department is seeking a Task Lead for the Advanced Battle... ...team in delivering timely, high-quality technical solutions and recommendations...QualityFor contractorsWork experience placementLocal area
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$45 - $49 per hour
...Get AI-powered advice on this job and more... ...closely with Medical, Research, and cross... ...teams to deliver high-quality epidemiologic analyses... ...Responsibilities Lead epidemiologic analyses... ...in pharma, medical device, or healthcare... ...3 days ago Senior Systems Analyst, Workday Data...QualityMedical deviceHourly payContract workRelocation1 day per week$100k - $116k
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