Iso 13485 Jobs

VahatiCor seeks a Process Development Engineer to lead catheter process development, transfer, and validation in its onsite Santa Clara manufacturing environment.

Cresilon is hiring paid Spring 2026 interns for a 15-week onsite program across nine technical and non-technical tracks, offering hands-on project experience at $30/hr.

Protolabs seeks a detail-oriented Quality Coordinator to manage document control, calibration programs, and quality reporting at its Plymouth manufacturing facility.

Foresight Diagnostics seeks a Senior Specialist, Regulatory Affairs to lead US regulatory strategy and submissions for next-generation sequencing-based IVD products while partnering cross-functionally through development and lifecycle management.

Lead a supplier engineering organization at Intuitive to drive supplier selection, development, performance and risk mitigation for high-volume medical device components.

Experienced maintenance planner needed to lead CMMS-driven scheduling, optimize preventive maintenance, and coordinate cross-functional resources at a regulated medical device manufacturing site in Roseville, CA.

Gilead is hiring an Associate Director of Device Engineering to lead and develop engineering teams delivering parenteral drug-device combination products while ensuring regulatory and design-control compliance.

Experienced Quality Engineer (contract) needed to lead quality systems, RCA, and continuous improvement for an electronics manufacturing client in Plainwell, MI.

Plexus is hiring a Design Assurance Engineer intern in Neenah, WI to assist with medical device compliance, verification testing, and risk management activities for new product development.

PROCEPT BioRobotics is hiring a Senior Supplier Quality Engineer to lead supplier assessments, audits, and corrective actions that ensure high-quality components and compliant manufacturing processes for its surgical robotics products.

Experienced document control professional needed to own DMS maintenance, ensure regulatory-compliant records, and support audits for a remote, regulated-healthcare-focused company.

Agilent’s Bioreagents team is hiring a Quality Control Analyst to perform IHC analytical testing and support QA activities across product lifecycle stages.

PROCEPT BioRobotics is looking for a Senior NPI Manufacturing Engineer to lead design-for-excellence, process validation, and manufacturing transfer for new electromechanical medical devices.

NeuroLogica seeks a Logistics & Inventory Manager in Danvers, MA to lead warehouse operations, inventory control, and logistics for our medical imaging manufacturing and service organization.

Lead end-to-end programs to deliver advanced health sensing features across hardware and software for a leading wearable health company.

Lead regulatory strategy and submissions for PROCEPT BioRobotics' surgical robotics products, guiding projects from development through market approval and post-market activities.

DeepHealth seeks a hands-on QA/RA Project Manager to drive quality, regulatory readiness, and cross-functional delivery for medical device software and digital health products in a fully remote role.

Lead verification for cloud-connected medical devices and mobile health applications as a Senior Verification Engineer/Lead based in Pleasanton, CA with IBA InfoTech.

GRAIL is hiring a Staff Quality Systems Specialist in Durham, NC to manage and improve eQMS-driven document control, records management, and training programs (Veeva experience highly preferred).

Lead regulatory strategy and submissions for device and combination products at AbbVie to ensure timely global approvals and compliance.

Lead product software strategy and regulatory-compliant development for a fast-growing molecular diagnostics company, driving validated, secure solutions that impact patient outcomes.

Artera is hiring a Systems Engineer to lead requirements, risk management, system architecture, and usability engineering for its AI medical-device products.

Foresight Diagnostics seeks an experienced VP of Product Software to lead regulated medical device software strategy, compliance, and validated product delivery across cross-functional teams.

VahatiCor is hiring a hands-on Quality Engineer with direct catheter device experience and ISO 13485 expertise to lead quality activities for catheter manufacturing and validation.

Lead validation and qualification efforts at Gerresheimer’s Peachtree City facility to ensure compliant, well-documented manufacturing and support processes for pharmaceutical and medical device products.

Vantive is hiring an early-career Disposables R&D Engineer to support design changes, V&V testing, prototyping, and regulatory-compliant development of Class II/III disposable medical devices in Plymouth, MN.

Abbott is hiring a Supplier Quality Engineer II in Westfield, IN to lead supplier audits, qualify vendors, and drive CAPA closure to maintain ISO/QSR compliance for Structural Heart products.

Abbott's Lingo division is hiring a Quality Engineer II to lead design control, CAPA, and risk-management activities for medical devices and SaMD from our Alameda, CA site.

Alphatec Spine seeks an experienced software engineering director to lead cross-functional teams developing embedded, mobile, web, and cloud solutions for intra-operative medical devices.

Lead hardware design and validation for Class III implantable devices at iota Biosciences, driving circuit innovation, prototyping, and regulatory-compliant documentation.

Manage a production value stream to deliver compliant, cost-effective medical devices through Lean/Six Sigma practices while coaching and developing production teams.

Lead systems-level solutions and sustaining engineering at Insulet as a Principal Systems Engineer, providing technical leadership across design, post-market support, and regulatory-compliant lifecycle activities.

Synchron is hiring a Quality Assurance Engineer to establish QC procedures, testing, calibration, and compliance practices for its San Diego team building brain–computer interface products.

Lead cross-functional continuous improvement for design quality at Insulet, implementing SDLC best practices and regulatory-aligned process improvements to accelerate compliant product development.

Abbott seeks a Senior Design Control Software Quality Engineer to validate and maintain Lingo product software and computerized quality systems in compliance with medical device regulations.

Experienced systems engineering leader needed to drive sustaining engineering, root-cause resolution, and regulatory-compliant product improvements for Insulet's wearable drug-delivery platform in a hybrid Massachusetts role.

Abbott is hiring a Software Quality Engineer II in Sylmar, CA to lead software validation, quality engineering, and regulatory compliance for non-product medical device software.

Lead opto-mechanical engineering for ophthalmic diagnostic and visualization devices at Alcon's Lake Forest R&D site, driving high-precision designs, validation, and transition to manufacturing.

Senior quality executive needed to lead Irvine and global laboratory operations, standardize best-in-class systems, and ensure regulatory compliance across the organization.

Lead and develop a Quality Engineering team in Abbott’s Electrophysiology division to drive manufacturing quality, regulatory compliance, and continuous improvement for Class II/III medical devices.

Senior Quality Systems Engineer needed to lead internal audits, manage QMS activities, and support regulatory compliance for GRAIL’s medical device and clinical laboratory operations in Durham, NC.

Lead and develop a team of trainers to deliver best-in-class learning solutions for laboratory automation and equipment at Exact Sciences’ Madison operations.

Abbott Neuromodulation seeks a Senior Operations QA Engineer in Plano, TX to drive quality improvement, data analytics, and regulatory compliance across manufacturing operations.

Intuitive seeks a senior Supplier Manufacturing Engineer (Plastics or Machining) to lead supplier qualification, DFM, and process controls for mission-critical components used in robotic-assisted surgery.

Senior Manufacturing Engineer role supporting da Vinci surgical systems through hands-on failure analysis, data-driven problem solving, and cross-functional process improvements at Intuitive.

Alcon is hiring a Principal Software Systems Engineer in Lake Forest, CA to own system and software requirements, ensure regulatory compliance, and architect safe, reliable medical digital platform solutions.

Lead technical project delivery and regulatory-compliant documentation for Oura's SaMD products, coordinating cross-functional teams to meet safety, quality, and regulatory requirements.

Experienced process engineer needed to lead development, validation, and scale-up of manufacturing processes for Cresilon’s hemostatic medical devices at the Brooklyn facility.

Experienced regulatory/quality professional needed to manage post-market surveillance, complaint handling, and global adverse event reporting for Kestra's cardiac device portfolio in a hybrid, Kirkland-based role.

Lead the regulated software product lifecycle at Foresight Diagnostics as Vice President, driving compliance and cross-functional innovation in medical device software development.