New

Manager, Supplier Quality

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 22, 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: iRhythm is currently seeking a Manager, Supplier Quality Assurance (SQA) who will report directly to the Sr. Director, Quality Operations and will be responsible for leading supplier quality team and initiatives in compliance with ISO 13485 and ISO 14971 standards, FDA21 CFR820 regulations and EUMDR. Key Responsibilities: * Manage and develop Supplier Quality Engineers to support the SQA initiatives and business. * Develop, implement, and manage Supplier Quality Programs in compliance with ISO 13485, FDA 21 CFR 820, and other relevant regulatory requirements. * Support purchasing controls through supplier selection process. * Lead supplier qualification, and approval processes in compliance with established processes and procedures. * Maintain Approved Supplier List (ASL), ensuring accurate records and risk assessments. * Review and approve supplier non-conformances, CAPAs, SCARs, to drive timely resolutions and continuous improvement. * Collaborate with Manufacturing and Engineering to develop risk mitigation strategies for supplier-related quality issues. * Support supplier-related changes as part of the Design Change Process and Product Development ensuring compliance with quality and regulatory requirements. * Support component qualification (first article inspections) and control plans for new or modified component suppliers as governed by internal procedures. * Provide guidance on receiving inspection plans and test method validation for component suppliers. * Monitor supplier performance through Key Performance Indicators (KPIs) and scorecards. * Oversee supplier audit program through scheduling, planning, and reporting. * Act as the primary representative for the Supplier Quality Program during internal and regulatory/notified body inspections. About you: Required Skills & Qualifications * Bachelor's degree in Engineering, Applied Science, Quality, or related field. * 5+ years in leadership role, preferably medical devices or pharma. * 7+years in Supplier Quality or Quality Operations for medical devices or pharma. * Strong understanding of ISO 13485 & ISO 14971 standards, FDA21 CFR820 regulations and EUMDR. * Experience in Quality Systems, Supplier Quality, Quality Audits, or Quality Operations. * Experience with QMS software platforms ( i.e. MasterControl, Veeva, TrackWise). * Experience with ERP platforms (i.e. QAD, SAP). * Detail-oriented with strong documentation and audit readiness skills. Preferred Qualifications * ISO 13485 Lead Auditor certification. * ASQ Certification * Six Sigma Certification (Green Belt or Black Belt preferred). * Experience with injection molding, PCBA, and printed materials (packaging and labeling). * Knowledge of statistical process control (SPC), Gage R&R, and Lean Manufacturing principles. 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 accommodation 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 $123,000.00 - $160,000.00 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.