Quality 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:

Acts as primary notification and consolidation point for receiving, processing, analyzing and reporting product complaints. Develops and updates company complaint and inspection procedures to ensure capture and investigation of complaints. Maintains and analyzes problem logs to identify and report recurring issues to quality assurance management and product development. Documents and tracks contact information, reported issues and problems in accordance with company guidelines and external regulatory requirements. May collaborate with other internal groups to respond to product inquiries and issues. May directly answer telephone "hot line" and written or Internet-based inquiries regarding company products. Individuals whose primary responsibility is interacting with customers, company sales and/or service representatives to handle a variety of pre-sales or post-sales service functions should be matched to Customer Service.

What You Will Be Doing

• Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.
• Performs and/or coordinates complaint investigations and gathering of additional information
• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete
• Ensures issues are being addressed and escalated in a timely manner
• Maintains complaints log.
• Participates in process improvements.
• Perform other quality and regulatory-related duties as assigned.

What We Want to See

• Bachelor's Degree or Associate Degree in science, technology or medical fields
• 3- 5 years of experience in Quality Assurance and / or a complaint processing role.
• Previous experience in medical devices with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR is an asset
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues.
• Understand basic principles of good technical writing skills and be able to articulate findings and formulate conclusions.
• Must work across functional teams within the organization and seek input from Product Quality, Product Development Engineers, and other departments for complaint investigation.
• Identify problems and lead projects to improve processes, procedures and/or practices; recommend and resolve solutions.
• Excellent communication (verbal and written) and interpersonal skills required.
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems.
• Basic knowledge of Quality Systems (CAPA/non-conformances/SCARS) a plus

Ways to Stand Out
* Must be able to work under minimum supervision and in a team environment.
* Must be a positive and energetic team player.
* Experience with software/firmware complaints a plus

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 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.

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 taops@irhythmtech.com. 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