New

Sr. Manager, Quality - CSV (nonproduct)

iRhythm Technologies, Inc.
life insurance, parental leave, paid holidays, long term disability, 401(k)
United States, California, San Francisco
699 8th Street (Show on map)
May 23, 2025
Career-defining. Life-changing. At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career About This Role: Boldly innovating to create trusted solutions that detect, predict, and prevent disease. Discover your power to innovate while making a difference in patients' lives. iRhythm is advancing cardiac care...Join Us Now! At iRhythm, we are dedicated, self-motivated, and driven to do the right thing for our patients, clinicians, and coworkers. Our leadership is focused and committed to iRhythm's employees and the mission of the company. We are better together, embrace change and help one another. We are Thinking Bigger and Moving Faster. About this role: This is a hybrid role, working 2-3 days per week out of our office in Cypress, CA. Key Responsibilities: Manage software lifecycle processes for non-product software in accordance with internal procedures and regulatory requirements. Develop and maintain validation protocols and reports (IQ, OQ, PQ) for nonproduct software systems. Ensure all systems used in support of GxP activities are validated and maintained appropriately. Collaborate with IT and functional departments to evaluate and select new software systems. Ensure change control and risk assessments are properly executed for system updates and upgrades. Lead or support internal/external audits (FDA, Notified Body) regarding non-product software. Maintain software inventory, validation documentation, and access control logs. Support data integrity initiatives and ensure Part 11/Annex 11 compliance of electronic records and signatures. Additional responsibilities may be assigned as necessary to support the business About You: Required Skills and Qualifications Bachelor's degree in Engineering, Computer Science, Quality, or related field. 8+ years in leadership role, preferably medical devices or pharma. 5+years in computer system validation for medical devices or pharma. Strong understanding of 21 CFR Part 11, ISO 13485, ISO 14971, GAMP 5, FDA guidance on software validation Experience with CSV (Computer System Validation) and lifecycle documentation. Experience with QMS software platforms( i.e. MasterControl, Veeva, TrackWise). Experience with ERP platforms (i.e. QAD, SAP) and manufacturing (SDM). Detail-oriented with strong documentation and audit readiness skills. What's in it for you: This is a regular full-time position with competitive compensation package, excellent benefits including medical, dental, and vision insurances (all of which start on your first day), health savings account employer contributions (when enrolled in high deductible medical plan), cafeteria plan pre-taxed benefits (FSA, dependent care FSA, commute reimbursement accounts), travel reimbursement for medical care, noncontributory basic life insurance & short/ long term disability. Additionally, we offer: emotional health support for you and your loved ones legal / financial / identity theft/ pet and child referral assistance paid parental leave, paid holidays, travel assistance for personal trips and PTO! iRhythm also provides additional benefits including 401(k) (with company match), an Employee Stock Purchase Plan, pet insurance discount, unlimited amount of LinkedIn Learning classes and so much more! FLSA Status: Exempt As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game. Location: Orange County Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range $146,000.00 - $190,000.00 As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all. Make iRhythm your path forward. Zio, the heart monitor that changed the game.