Iso 13485 Jobs

Lead the Design Quality team at PROCEPT BioRobotics to drive product qualification, risk management, and regulatory compliance for surgical robotic instruments and consumables.

Lead the end-to-end development of a next-generation Class II ventilator as a hands-on Technical Project Manager who bridges engineering, regulatory, and manufacturing to deliver clinical-grade products.

Support and troubleshoot sequencing system hardware, software, and chemistry components in a lab-focused engineering role at Illumina to help enable genomic discoveries.

Senior-level systems engineer needed to drive system architecture, requirements, risk management and design validation for complex drug/device combination products at AbbVie's North Chicago site.

Medtronic is seeking a Sr. Engineering Manager to lead electrical and firmware reliability efforts for cardiac implantable devices, ensuring safety, compliance, and high product reliability while growing a technical team.

Penumbra seeks a Senior Quality Engineer in Roseville, CA to lead quality engineering, process and supplier development for medical device products while ensuring regulatory compliance and product reliability.

Experienced quality engineer needed to support medical device design control, risk management, and verification/validation activities for Haemonetics' product portfolios in Clinton, PA.

Become a key quality representative at Illumina, driving design control, risk management, and regulatory compliance for products that impact human health.

Lead device and combination product regulatory strategy and submissions for AbbVie's Eyecare portfolio in a hybrid Senior Manager, Regulatory Affairs Device role based in Irvine, CA.

Lead the quality engineering team at NeuroLogica's Danvers HQ to ensure high-reliability CT products through testing strategy, continuous improvement, and regulatory-compliant processes.

EnsoData is hiring a QA Engineer to architect and build a scalable E2E UI automation framework and lead verification for FDA-cleared SaMD in a hybrid Madison, WI role.

Teguar is hiring a Quality Engineer to support QMS activities, internal audits, supplier and customer quality, and continuous improvement across medical and industrial product lines.

Experienced QA professional needed to support LGC Clinical Diagnostics’ Milford site in ensuring product quality, managing QMS processes, and driving continuous improvement within a regulated IVD manufacturing environment.

Sanofi is hiring a Quality Manager (CMO) to lead GxP quality oversight of external manufacturers and labs, ensuring compliant product release and supplier performance.

GRAIL is hiring an Operations Engineer 2 to support, troubleshoot, and maintain NGS and automated lab equipment at its Durham RTP facility to enable reliable early-cancer detection workflows.

Cresilon offers a paid 10-week onsite summer internship program where interns work on focused projects across R&D, Quality, Manufacturing, Data Analytics, Regulatory, and related functions to gain hands-on industry experience.

Lead cross-functional QMS improvement projects at Penumbra to ensure regulatory compliance and drive system-driven quality solutions.

Experienced RA/QA professional needed to support CAPA management, vendor qualification, documentation control, and audit readiness for a MedTech CRO on a remote, temporary contract.

Experienced medical device program leader needed to own strategic client portfolios, drive cross-functional delivery, and grow Eurofins’ footprint across testing and consulting services.

Eko seeks a Senior Mechanical Engineer to drive mechanical design, prototyping, verification, and scale manufacturing of its next-generation digital stethoscopes.

Eko is hiring a hybrid Product Quality Assurance Engineer to lead QMS activities, design control, and risk/validation efforts for FDA-regulated hardware+software medical devices.