Senior CSV Engineer (Non-Product Systems)

iRhythm Technologies, Inc.; California (MO); Hybrid; USD 112,000 - 145,000; Full time

Job summary

A leading medical technology firm in California is seeking a Senior Quality Engineer for a hybrid role focused on validating non-product computerized systems. The ideal candidate will possess a Bachelor's degree and 5+ years in software assurance with strong regulatory knowledge. This position offers a competitive salary range of $112,000 to $145,000 annually and requires collaboration across quality assurance and IT to ensure compliance with industry standards.

Qualifications

• 5+ years in CSV/software assurance in medical device, pharma, or biotech.
• Strong knowledge of regulatory frameworks and GAMP5 guidelines.
• Skilled in cloud/on-premise systems validation and audit readiness.

Responsibilities

• Lead validation activities for GxP-relevant non-product systems.
• Ensure compliance with FDA, ISO, and EU requirements across software lifecycle.
• Support audits and inspections with CSV expertise.

Skills

CSV/software assurance

Regulatory knowledge

QMS/ERP systems

SDLC validation

Organized and detail-oriented

Education

Bachelor’s in Engineering, Computer Science, Life Sciences

Tools

MasterControl

Veeva

SAP

Job description

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

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