On-Site Production Lead – Medical Devices

iRhythm Technologies, Inc.; California (MO); On-site; USD 70,000 - 110,000; Full time

Job summary

iRhythm Technologies, Inc. seeks a Production Supervisor to oversee daily manufacturing operations on-site, ensuring safety, quality, and timely output. You will lead a team, enforce GMP and GDP standards, and collaborate with Engineering, Quality, and Supply Chain to sustain high-quality medical devices.

The role requires 3–5 years in manufacturing with supervisory experience, plus knowledge of ISO 13485 and FDA 21 CFR Part 820. Strong communication and problem-solving skills are essential.

Qualifications

• Associate degree or equivalent experience required; Bachelor’s degree preferred.
• 3–5 years in manufacturing operations with 1–2 years in a supervisory role.
• Experience in medical device or regulated industry is preferred.
• Knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP requirements.
• Familiarity with ERP or MRP systems such as QAD, SAP, or Oracle.
• Strong communication, problem-solving and organizational skills.

Responsibilities

• Supervise daily production operations to meet safety, on-time, and quality targets.
• Maintain compliance with FDA/ISO 13485 and other medical device regulations.
• Communicate daily goals and performance expectations to the team.
• Lead and develop manufacturing associates; coach on SOPs and GDP/GMP practices.
• Schedule production with planning and supply chain; manage documentation and deviations.

Skills

Leadership

GMP experience

SOP adherence

Quality systems

Problem solving

Communication

ERP/MRP

Regulatory knowledge

Education

Associate degree or equivalent

Bachelor’s degree in Engineering/Manufacturing

Tools

QAD

SAP

Oracle

Job description

iRhythm Technologies, Inc. seeks a Production Supervisor to oversee daily manufacturing operations on-site, ensuring safety, quality, and timely output. You will lead a team, enforce GMP and GDP standards, and collaborate with Engineering, Quality, and Supply Chain to sustain high-quality medical devices.

The role requires 3–5 years in manufacturing with supervisory experience, plus knowledge of ISO 13485 and FDA 21 CFR Part 820. Strong communication and problem-solving skills are essential.