Senior CSV Engineer (Non-Product Systems)

iRhythm Technologies, Inc. provided pay range

This range is provided by iRhythm Technologies, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range

$112,000.00/yr - $145,000.00/yr About the Role: As a

Senior Quality Engineer – Computer System Validation (CSV) , you’ll support validation and compliance efforts for non-product computerized systems used across manufacturing, quality, and business operations at iRhythm. You’ll ensure these systems meet regulatory standards such as FDA 21 CFR Part 11/820, ISO 13485, and EU MDR. This hybrid, full-time role is based in

Cypress, CA , with

3 in-office days per week . Key Responsibilities: Lead validation activities for GxP-relevant non-product systems. Ensure compliance with FDA, ISO, and EU requirements across the software lifecycle. Collaborate with IT, QA, and vendors to manage system validation and change controls. Review and approve validation deliverables (e.g., plans, protocols, reports). Maintain system inventory and documentation per retention policies. Support audits and inspections with CSV expertise. Promote data integrity and compliance with Part 11/Annex 11 standards. About You: Bachelor’s in Engineering, Computer Science, Life Sciences, or related field. 5+ years in CSV/software assurance in medical device, pharma, or biotech. Strong knowledge of regulatory frameworks and GAMP5 guidelines. Experience with QMS/ERP systems (e.g., MasterControl, Veeva, SAP). Skilled in SDLC, cloud/on-premise systems validation, and audit readiness. Organized, detail-oriented, and capable of managing multiple projects. Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

Job function Quality Assurance Industries Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at iRhythm Technologies, Inc. by 2x Sign in to set job alerts for “Product Engineer” roles.

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