21 Cfr Jobs

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.

Smith+Nephew is hiring a Laboratory Validation Specialist to lead lab method validations, equipment qualifications, and computer system validation activities in a GMP-regulated laboratory at the Fort Worth facility.

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 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.

AbbVie seeks an Associate Data Analyst in Tempe to manage vigilance reporting, regulatory submissions, and stakeholder communications for pharmaceutical and device complaints.

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.

Computer Software Validation Specialist to lead validation, testing, and compliance for GxP-regulated software implementations at Syner-G's San Diego operations.

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

BioAgilytix is hiring a Quality Validation Engineer II to lead computer system validations and equipment qualifications for GxP-regulated laboratory systems, ensuring compliance with 21 CFR Part 11, GAMP, and related standards.

eClinical Solutions is looking for a Principal Technical Project Manager to lead technical delivery and client-facing project management for the elluminate Clinical Data Cloud across complex clinical programs.

Agilent is hiring a Software Quality Engineer to execute hands‑on testing and ensure product quality for laboratory automation and instrument control systems in a regulated environment.