Senior CSV Engineer (Non-Product Systems) - iRhythm Technologies : Job Details

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 levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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