Senior CSV Engineer

2 weeks ago

California, United States iRhythm Technologies, Inc. Full time

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. Brea, CA $84,000.00-$101,000.00 1 week ago Irvine, CA $125,000.00-$169,800.00 1 week ago Orange, CA $80,000.00-$100, hours ago Irvine, CA $85,400.00-$94,900.00 2 weeks ago Huntington Beach, CA $90,000.00-$160,000.00 3 months ago Irvine, CA $175,000.00-$200,000.00 2 weeks ago Anaheim, CA $90,000.00-$110, hours ago Sr Mechanical Design Engineer - Consumer Goods Irvine, CA $120,000.00-$150,000.00 1 day ago Lake Forest, CA $70,000.00-$95,000.00 2 days ago Irvine, CA $95,825.00-$117,120.00 1 week ago Irvine, CA $119,076.00-$145,537.00 2 weeks ago Manufacturing Engineer - New Product Introduction (NPI) Fullerton, CA $90,000.00-$115,000.00 3 weeks ago Placentia, CA $90,000.00-$115,000.00 3 weeks ago Orange, CA $90,000.00-$115,000.00 3 weeks ago Quality Engineer/Aerospace Manufacturing Sr. Mechanical Design & Release Engineer - Wheels Irvine, CA $107,000.00-$134,800.00 1 day ago Santa Ana, CA $90,000.00-$115,000.00 3 weeks ago Manufacturing Engineer, EOL & Electrical Diagnosis Senior Vehicle Accessory Product Development Engineer Irvine, CA $176,200.00-$220,300.00 1 week ago Irvine, CA $90,000.00-$120, hours ago Irvine, CA $95,000.00-$180,000.00 1 week ago Santa Ana, CA $75,000.00-$110,000.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

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