Manager, Quality Assurance

Role Overview

Join iRhythm's Quality team as a Manager, Quality Assurance. Oversee Post Market Complaints and Document Management team to ensure compliance, accuracy, and efficiency. Provide leadership, guidance, and feedback to the team.

What You Will Do

Provide supervision and leadership to team of Complaint Investigators and Document Management Specialists. Manage and balance assignment of work to team to meet goals. Review investigated complaints to ensure procedural and regulatory compliance.

Why It Might Be a Fit

We are looking for like-minded individuals who are quality driven and patient focused to join our team. You will have the opportunity to grow your skills and your career while impacting the lives of people around the world.

Requirements

• Bachelor’s Degree or Associate Degree in science, technology or medical fields
• 8+ years of experience in Quality Assurance, preferably in Complaint Handling and/or Post Market roles
• 2+ years of experience as a Manager or Supervisor in a medical device company
• Strong working knowledge of ISO 13485, FDA 21 CFR 820, European Union MDD /MDR
• Strong interpersonal and organizational skills to enable working cross-functionally within the organization
• Strong problem-solving skills, critical-thinker, and experience at investigating and resolving complex issues
• Excellent communication (verbal and written) and interpersonal skills required
• Demonstrated experience with MS Word, Excel, Adobe Acrobat, and other commonly used software systems

Benefits

• Excellent benefit and salary package
• Competitive compensation
• Reasonable accommodations for qualified individuals with disabilities in job application procedures