Iso 13485 Jobs

Lead Medtronic's Quality Engineering team in Grand Rapids to ensure cardiac surgery devices and processes meet regulatory standards and drive continuous quality improvement.

As Lead Quality Engineer at GE HealthCare, you will drive QMS execution for digital production and process controls, ensuring regulatory compliance and process effectiveness across product lifecycle stages.

Experienced regulatory professional needed to lead post‑market compliance, field actions, and regulatory communications for Stryker’s Endoscopy Division across global operations.

Experienced post-market quality professional needed to manage complaint investigations, generate KPI reporting, and support MDR/FAR vigilance activities for a major medical products company.

AbbVie is hiring a Senior Quality Engineer to lead design quality, risk management and regulatory readiness for late-stage combination product and medical device development at the North Chicago campus.

PROCEPT BioRobotics seeks a Senior Quality Engineer to drive design controls, risk management, and V&V for disposables and accessories while ensuring compliance with FDA QSR, ISO 13485, and EU MDR.

As a Validation Engineer 2 at Illumina's San Diego site, you will lead validation strategy, execute IQ/OQ/PQ and testing activities, and ensure compliance with regulatory and quality standards for manufacturing processes and systems.

Lead the engineering transformation at Alcon's Houston manufacturing site by delivering automation, Industry 4.0, CI-driven savings, and an energy transition while building a high-performing engineering organization in a regulated environment.

Lead and scale cross-site CNC machining and rapid prototyping operations to deliver ultra-precision components for Neuralink’s medical devices and surgical systems.

Lead catheter and mechanical systems development for a fast-moving IVUS medical device startup, owning design through prototype, testing, and manufacturing handoff.

Intuitive is hiring a Continuous Improvement Quality Engineer to lead NC/CAPA activities and drive quality system improvements for its robotic surgery products in a regulated manufacturing setting.

Lead mechanical design and development of next-generation minimally invasive surgical robots at Intuitive, applying deep mechanical engineering expertise to prototype and production systems.

Medtronic is hiring a Quality Engineer II to support on-site manufacturing quality for Class II surgical devices in Boulder, focusing on investigations, corrective actions, validation, and process improvements.

Technical regulatory leader sought to author and drive FDA regulatory strategy and submissions for AI/ML-enabled SaMD at a fast‑moving digital health company.

Medtronic is hiring an experienced Engineering Manager to lead device development teams at its Mounds View facility, combining technical depth and strategic leadership to accelerate compliant product delivery.

Medtronic is hiring a Post Market Quality Engineer II to analyze post-market data, conduct health risk assessments, and support CAPA and regulatory compliance efforts to improve device safety and performance.

ARK Diagnostics is hiring a Regulatory Affairs Specialist II to own international product registrations, support submissions (e.g., 510(k), De Novo, IVDR), and maintain regulatory compliance at its Fremont, CA facility.

Lead quality strategy and design-control activities for next-generation robotic-assisted surgical products at a market-leading medical device company.

Stryker seeks a Senior Quality Assurance Engineer to lead validation, quality improvement, and risk-reduction activities at its Irvine manufacturing site.

Experienced V&V engineer needed to lead verification and validation efforts for software-enabled medical devices, ensuring regulatory compliance and product quality across cross-functional teams.

ARK Diagnostics is hiring a Regulatory Affairs Specialist II to manage international device registrations, prepare regulatory submissions (including 510(k), De Novo, and IVDR technical documentation), and support lifecycle compliance for IVD and medical device products.

Medtronic is hiring a Senior Engineering Program Manager (Quality Core Team Member) to lead quality strategy and design assurance for cardiac surgery product development in Brooklyn Park, MN.

Medtronic is seeking a Product Engineer II to own design support and continuous improvement for wound management devices in high-volume production, focusing on yield, root cause analysis, supplier changes, and device quality.

Cellanome is hiring a Staff Technical Program Manager to lead cross-functional instrument development programs (hardware, software, assay, systems integration) and drive on-time delivery from concept through V&V in San Diego.

Nextern is looking for a Senior Systems Engineer to lead system architecture, risk management, and verification/validation for electro-mechanical medical device projects.

Experienced regulatory/quality professional needed to maintain QMS activities, drive CAPA and change control, and support audit and regulatory documentation for a growing medical device company in New York State.

Senior Electrical Manufacturing Engineer to own and lead PCBA, cable/harness, controller, and battery manufacturing and validation in an FDA-regulated Class III medical device environment at BiVACOR in Huntington Beach, CA.

Senior Quality Engineer at Penumbra responsible for supporting manufacturing operations and driving quality, inspection, and yield improvements across medical device production lines.

Eurofins is hiring a Quality Assurance Manager in San Jose to lead QA/QC/regulatory activities, maintain compliance with industry standards, and drive improvements across the laboratory quality system.

Lead statistical analysis and BI-driven quality metric programs at BD’s Covington manufacturing site to support complaint trending, CAPA, audits, and continuous improvement.

Intuitive Surgical seeks a Senior Service Business Analyst (MRO) to define and deliver SAP S/4HANA-enabled service supply chain solutions that improve repair, inventory, planning, and quality visibility.

Activ Surgical seeks a Senior Sustaining Engineer to lead manufacturing support, sustaining engineering, and design-for-manufacture improvements for its laparoscopic visualization platform.

Penumbra is hiring a Quality Engineer I to support manufacturing, design control, and QMS activities for innovative medical devices at its Alameda, CA site.

Experienced quality systems professional needed to lead compliance for field actions and regulatory engagements at a leading robotic-assisted surgery company in Sunnyvale, CA.

Lead a small engineering team on-site in Durham to provide hands-on technical leadership and maintenance for complex laboratory automation, ensuring regulatory compliance and continuous operational reliability.

LGC Biosearch Technologies is hiring an Oligo Manufacturing Technician (Swing Shift) to support oligonucleotide production and quality-compliant manufacturing activities at the Petaluma site.