About iRhythm:

iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm's continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.

About this role:

iRhythm Technologies, Inc. is looking for a Quality Specialist – Post Market to join the Quality team. The Quality Specialist – Post Market will provide hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day-to-day complaint review, investigation reports, adverse event reporting, and complaints log and trend maintenance. This position will be based on site in Cypress, CA 1-2 days per week.

Our work environment is a fast-paced atmosphere, fostering excellent cross-functional collaboration. Most of all, we are passionate about delivering innovations that improve the quality of health care and the patient experience. We are looking for like-minded individuals who are quality driven and patient focused to join our team!

Responsibilities:

• Investigates complaints to determine complaint cause, completes Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting.
• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports
• Evaluates all information from a technical perspective to ensure appropriate Analysis and Investigation
• Reviews daily processes to ensure 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

Skills and Knowledge

• Bachelor's Degree
• Minimum of 2 years of experience in Quality Assurance with complaint processing role.

• Previous experience in medical device with working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
• Must demonstrate the ability to investigate complaints with minimal guidance.
• Strong problem-solving skills, critical-thinker, and experienced at investigating and resolving complex issues
• Understand basic principles of good technical writing skills
• Background with firmware/hardware related complaints investigation a plus
• Attention to detail and timeliness are critical
• 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
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player