Quality Specialist-Post Market

iRhythm Technologies, Inc.

10d • $72,000 - $90,000 • Remote

About The Position

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.

Requirements

• 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
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player.

Nice To Haves

• Experience with software/firmware complaints a plus

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees