Lead Electronics Medical Device Production Supervisor

MAC Incorporated; Orange (CA); On-site; USD 68,000 - 90,000; Full time

Job summary

MAC Incorporated is seeking a Production Supervisor for our Orange, CA facility slated to begin production in 2027. The role focuses on electronics/PCBA manufacturing, with ISO 13485 and FDA QMSR compliance as core requirements.

The successful candidate will lead a team, manage schedules, ensure safety and quality, and drive continuous improvement. This on-site position offers a day shift (8am‑5pm) and a base salary around $80k with a potential performance bonus.

Qualifications

• High school diploma is required; associate degree or technical training preferred.
• 3+ years of experience in a regulated manufacturing environment, electronics or medical device manufacturing preferred.
• ISO 13485, FDA QMSR/21 CFR Part 820, GMP, GDP experience preferred.
• Strong leadership with a track record of coaching and developing teams.
• English and Mandarin proficiency preferred, but not required.

Responsibilities

• Supervise electronics assembly, PCBA assembly, cable/wire harness assembly, soldering, inspection, testing, and packaging.
• Assign daily work and manage production schedules to meet customer demand and delivery commitments.
• Ensure production follows SOPs, work instructions, DHRs, BOMs, drawings, and quality procedures.
• Maintain compliance with ISO 13485, FDA QMSR/21 CFR Part 820, GMP, GDP, and ESD requirements.
• Ensure proper product identification, traceability, labeling, material segregation, and lot/serial number control.
• Identify and escalate nonconforming products, failed tests, process deviations, equipment issues, and quality concerns.
• Support root cause investigations, CAPA, process validation, equipment qualification, and continuous improvement.
• Train employees on SOPs, ESd practices, safety procedures, and quality expectations.
• Maintain production records, DHRs, inspection/test records, rework documentation, and shift reports.

Skills

Production leadership

Electronics/PCBA manufacturing

Quality and regulatory compliance

ESD controls

Traceability

Root cause analysis

Production scheduling

Communication

Safety

Documentation

Education

High school diploma

Associate degree or technical training

Tools

ERP/MES experience

Job description

MAC Incorporated is seeking a Production Supervisor for our Orange, CA facility slated to begin production in 2027. The role focuses on electronics/PCBA manufacturing, with ISO 13485 and FDA QMSR compliance as core requirements.

The successful candidate will lead a team, manage schedules, ensure safety and quality, and drive continuous improvement. This on-site position offers a day shift (8am‑5pm) and a base salary around $80k with a potential performance bonus.