Senior QA Specialist- Post Market

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:

The Senior Specialist, Post-Market Surveillance is an experienced quality professional responsible for evaluating, investigating, and reporting medical device complaints in accordance with global regulatory requirements. This role manages complex complaint investigations, determines reportability under FDA and international regulations, and ensures high-quality documentation to support regulatory submissions and internal decision-making. The Senior Specialist collaborates across multiple departments, contributes to post-market process improvements, and supports internal and external audits related to complaint handling.Sample Job Descriptions can be found here: Job Description Library

What You Will Be Doing

• ·Evaluate complaints to determine reportability in accordance with 21 CFR Part 803, EU Vigilance, UK MHRA, and other global reporting requirements.
• Perform and/or coordinate complex complaint investigations, including gathering additional information from internal and external sources.
• Analyze complaint information from a technical and regulatory perspective to ensure investigations are complete, accurate, and well-justified.
• Work closely with Clinical Operations, Product Quality, Engineering, Intake, and R&D to complete high-quality investigation reports.
• Ensure complaint issues are escalated, resolved, and documented in a timely manner.
• Maintain complaint logs, documentation, and trending data in compliance with Quality System requirements.
• Draft, review, and support submission of MDRs/MIRs and other global adverse event reports.
• Participate in process improvement initiatives to enhance complaint handling efficiency and compliance.
• Train team members or cross-functional partners on complaint handling and post-market surveillance procedures.
• Perform peer reviews of investigations to ensure clear, complete, and regulatory-compliant documentation.
• Support internal and external audits, including FDA and notified body audits.

What We Want To See

• At least five years of related experience in Quality Assurance or complaint processing within the medical device industry with a Bachelor’s degree; or at least 3 years of experience with a Master’s degree; or PhD without prior experience; or equivalent combination of education and experience.
• Strong knowledge of medical device regulations, including ISO 13485, FDA 21 CFR 820, and familiarity with MDD/MDR requirements.
• Demonstrated expertise in technical writing, producing clear, accurate, and well-supported investigation reports.
• Strong analytical and problem-solving skills with experience resolving complex issues.
• Ability to work cross-functionally and communicate effectively with Clinical Operations, Quality, Engineering, R&D, and other teams.
• Proficiency with MS Word, Excel, Adobe Acrobat, and commonly used quality or complaint handling systems.
• Knowledge of CAPA, non-conformance, or SCAR processes is a plus.
• Excellent verbal and written communication skills; ability to work independently with minimal supervision.

Work Environment and Other Requirements

· Ability to work in a hybrid or remote environment, depending on business needs.

· May require occasional onsite presence for audits, training, or cross-functional collaboration.

· Must be able to manage multiple priorities in a fast-paced, highly regulated environment.

· Occasional overtime may be required to meet regulatory reporting timelines.

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

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 [email protected]

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.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact [email protected]. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121