Production/ RMA Lead opening in Orange CA. We are looking for a strong production/ RMA lead who comes electronics assembly manufacturing environment. Must have computer knowledge to conduct basic repair and troubleshooting.

Salary $80k with potential performance bonus

Production / RMA Lead – Medical Computer Manufacturing

Position Summary

The Production/RMA Lead is responsible for leading the day-to-day RMA and refurbished goods production process within an electronics medical device manufacturing environment. This is a hands-on leadership role overseeing returned product inspection, diagnostics, testing, refurbishment, documentation, and final disposition.

The Lead ensures products are processed accurately and on time while maintaining compliance with ISO 13485, FDA QMSR/21 CFR Part 820, ESD, quality, and production requirements.

Key Responsibilities

• Lead and organize the daily workflow of the RMA, testing, and refurbishment team.
• Manage returned products from receipt through inspection, diagnostics, repair/refurbishment, testing, and shipment.
• Perform and oversee hardware diagnostics, software/firmware updates, testing, and quality inspections.
• Train employees on RMA procedures, work instructions, testing, documentation, ESD controls, and quality standards.
• Monitor team productivity, turnaround times, quality, and workflow bottlenecks.
• Ensure production and RMA activities follow approved SOPs, BOMs, assembly drawings, quality plans, and work instructions.
• Maintain product identification, component traceability, serial/lot control, labeling, and material segregation.
• Identify and escalate nonconforming products, failed tests, process deviations, equipment issues, and quality concerns.
• Maintain accurate RMA, production, inspection, testing, rework, and Device History Record (DHR) documentation.
• Enter and maintain records using ERP systems such as Microsoft Dynamics Business Central or NetSuite.
• Analyze product failures and return trends to support root cause analysis, CAPA, and continuous improvement.
• Work with Engineering, Quality, Procurement, Operations, and other departments to resolve recurring product issues.
• Communicate RMA status and resolution information to customers and internal teams.
• Maintain a clean, safe, organized, 5S and audit-ready production environment.

Qualifications

• CompTIA A+ certification strongly preferred.
• High School Diploma/GED required; Associate Degree or technical training in electronics, manufacturing, engineering, or related field preferred.
• 3+ years of experience in a regulated manufacturing environment.
• Electronics or medical device manufacturing experience strongly preferred.
• Previous experience as a Lead, Trainer, Production Lead, or acting Supervisor preferred.
• Knowledge of ISO 13485, FDA QMSR/21 CFR Part 820, GMP, GDP, CAPA, and nonconformance processes preferred.
• Experience with electronics troubleshooting, testing, ESD controls, traceability, and production documentation.
• Ability to read work instructions and technical production documentation.
• Basic Microsoft Office skills; ERP/MES experience preferred.
• Strong troubleshooting, communication, organization, and leadership skills.
• English and Mandarin Chinese proficiency preferred, but not required.

Work Environment

Work is performed in an electronics/medical device manufacturing environment involving PCBA assembly, testing, inspection, refurbishment, packaging, and warehouse activities. Employees may work around soldering equipment, electronic components, test fixtures, calibrated equipment, and hand tools and must follow all required ESD, PPE, safety, quality, and contamination-control procedures.

Reports To: Director of Business Operations

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