Quality Control Leader – Medical Devices & Compliance

iRhythm Technologies, Inc.; Anaheim (CA); On-site; USD 112,000 - 145,000; Full time

Job summary

iRhythm Technologies, Inc. in Orange County is seeking a Quality Control Manager to lead QC execution across manufacturing and receiving, owning inspection, documentation, material control, and disposition activities on the shop floor.

The role requires ISO 13485 and FDA 21 CFR 820 knowledge, guiding nonconformance and MRB processes, batch record review, and continuous improvement through Gemba leadership and data-driven decisions.

Qualifications

• Bachelor's degree in Life Sciences, Engineering or related field.
• Minimum 8 years in medical device quality/control roles and leading QC teams.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820; familiarity with EU regulations.
• Proven ability to identify, investigate, and resolve complex quality issues including MRB and deviations.
• Excellent verbal and written communication; able to lead cross-functional teams.

Responsibilities

• Lead, coach, and develop QC Inspectors and Receiving staff.
• Ensure inspections, documentation, and material disposition follow approved procedures.
• Own batch record review, MRB, deviations, and containment actions.

Skills

Leadership

Quality management

ISO 13485

FDA 21 CFR 820

Gemba walks

Communication

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree preferred

Tools

Statistical tools (Cp/Cpk, Pp/Ppk)

Gage R&R

Job description

iRhythm Technologies, Inc. in Orange County is seeking a Quality Control Manager to lead QC execution across manufacturing and receiving, owning inspection, documentation, material control, and disposition activities on the shop floor.

The role requires ISO 13485 and FDA 21 CFR 820 knowledge, guiding nonconformance and MRB processes, batch record review, and continuous improvement through Gemba leadership and data-driven decisions.