21 Cfr 820 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.

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.

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 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 end-to-end vigilance and regulatory reporting for pharmaceuticals, medical devices, and combination products for AbbVie's Tempe site on a hybrid schedule.

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.

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.

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