Manager, Quality Assurance

Responsibilities

• Provide supervision and leadership to a team of Complaint Investigators and Document Management Specialists
• Manage and balance work assignments to ensure team goals are met
• Provide guidance, development, and performance feedback through regular one-on-one and team meetings
• Conduct annual performance reviews and quarterly check-ins
• Review investigated complaints to ensure procedural and regulatory compliance
• Manage and respond to regulatory body inquiries regarding reported complaints
• Ensure documents and complaints are managed and closed in a timely manner, meeting all global medical device reporting timeframes
• Participate in process improvement initiatives to enhance compliance, effectiveness, and efficiency

Requirements

• Bachelor’s or Associate degree in science, technology, or medical fields
• 8+ years of experience in Quality Assurance, preferably in Complaint Handling or Post Market roles
• 2+ years of experience as a Manager or Supervisor within a medical device company
• Strong working knowledge of ISO 13485, FDA 21 CFR 820, and EU MDD/MDR
• Proficiency in MS Word, Excel, and Adobe Acrobat
• Strong problem-solving, critical-thinking, and technical writing skills
• Ability to work effectively in a fast-paced, cross-functional team environment

About the Company

iRhythm Technologies, Inc. is a leading digital healthcare company that creates trusted solutions to detect, predict, and prevent disease. By combining wearable biosensors and cloud-based data analytics with proprietary algorithms, iRhythm transforms heartbeats into clinically actionable information to improve patient outcomes and reduce healthcare costs.