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:

Oversees development and implementation of standards, methods, and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products. Ensures finished products conform to government and company standards regulations. Develops and performs tests to ensure that products meet quality standards. Reports findings, make recommendations for improvement. Interprets drawings, prints, schematics and quality assurance standards. This job family is in the professional level category and works independently with flexibility and authority over daily work priorities. Incumbents in this job level category may provide work direction to other employees but would not typically have the authority to discipline or reward other employees. There are different levels available that provide clarity on contribution expectations based on knowledge, application, problem solving, and collaboration. The Multi-Focus attribute is typically reserved for roles that either: (1) are fully described by their area or function description; or (2) span multiple disciplines, products, or focuses of expertise.

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, working closely with other departments to complete investigation reports

• 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
• Must be able to work under minimum supervision and in a team environment.
• Must be a positive and energetic team player.
• Must be able to work at office for near future, shifting to hybrid once onboarding is complete.
• Experience with software/firmware complaints a plus.