Manager, Post Market Engineering (Onsite) (Orange County)

About this role :

iRhythm Technologies, Inc. is looking for a Manager, Post Market Engineering to join the Quality team. The Post Market Engineering Manager will oversee the Post Market Quality Engineering team to ensure compliance, accuracy, and efficiency, including oversight over a Complaints Lab. The position will also provide data and analysis to support Quality department as needed.

Responsibilities :

• Provide supervision and leadership to a team of Quality Engineers and Complaints Technicians.
• Manage and balance assignment of work to team to meet goals.
• Provide guidance, development and performance feedback and opportunities for growth through regular one-one-one and team meetings.
• Annual Performance reviews with quarterly check-ins
• Establish and maintain documented laboratory procedures
• Manage and update testing methods, techniques and equipment, as needed
• Review investigated complaints to ensure procedural and regulatory compliance.
• Ensures complaints are closed in a timely manner, ensures all global medical device reports are submitted within regulatory timeframes.
• Manages projects associated with the Complaint Handling process
• Participates in process improvements to improve compliance, effectivity, and efficiency, and takes ownership for updating procedures and policies.
• Perform other quality and regulatory-related duties as assigned.

Required Qualifications :

Work Environment