On-Site 2nd Shift Production Lead - Medical Devices

El Camino Health; Orange (CA); On-site; USD 70,000 - 88,000; Full time

Job summary

iRhythm Technologies, Inc. in Orange County, CA is seeking a Production Supervisor for the 2nd shift (3pm–11pm PST) to lead day-to-day manufacturing operations on-site.

You will drive safety, quality, and delivery while coordinating with Engineering, Quality, and Supply Chain to meet production goals. Qualified candidates have 3–5 years in manufacturing, 1–2 years in supervision, and a strong grasp of GMP, ISO 13485, and FDA 21 CFR Part 820.

Qualifications

• Associate degree or equivalent experience required; Bachelor's degree preferred.
• Experience in manufacturing operations; 3–5 years, with 1–2 years in a supervisory role.
• Knowledge of medical device manufacturing regulations (FDA, ISO 13485) and GMP.

Responsibilities

• Supervise daily manufacturing operations to meet production schedules safely and to quality standards.
• Ensure compliance with FDA, ISO 13485 and other medical device regulations; maintain quality records.

Skills

Medical device manufacturing

Quality systems (ISO 13485, FDA 21 CFR

GMP requirements

ERP/MRP systems (QAD, SAP, Oracle)

Communication & leadership

Continuous improvement

Education

Associate degree or equivalent experience

Bachelor's degree in Engineering/Manufacturing or related field preferred

Tools

QAD

SAP

Oracle

Job description

iRhythm Technologies, Inc. in Orange County, CA is seeking a Production Supervisor for the 2nd shift (3pm–11pm PST) to lead day-to-day manufacturing operations on-site.

You will drive safety, quality, and delivery while coordinating with Engineering, Quality, and Supply Chain to meet production goals. Qualified candidates have 3–5 years in manufacturing, 1–2 years in supervision, and a strong grasp of GMP, ISO 13485, and FDA 21 CFR Part 820.