Calibration & Maintenance Team Lead — Medical Devices

Life Science Outsourcing, Inc.; Brea (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Life Science Outsourcing, Inc. in Brea, CA is seeking a Calibration and Maintenance Supervisor to lead two mission-critical programs, drive maintenance and calibration across shifts, and ensure compliance with FDA QMSR and ISO 13485 standards.

You will own programs, supervise technicians, manage records, and collaborate with Quality and Engineering to minimize downtime while maintaining GMP and GDP standards in a fast-paced CMO environment.

Qualifications

• 5 to 7 years of calibration, metrology, and/or preventive maintenance experience in regulated manufacturing.
• 2 to 3 years in a lead or supervisory capacity.
• Familiarity with FDA QMSR (21 CFR Part 820) and ISO 13485:2016.

Responsibilities

• Lead a team of maintenance and calibration technicians across shifts.
• Own the full calibration program: master schedule, intervals, and OOT investigations.
• Maintain records in the EQM System and ensure GDP/compliance.
• Oversee preventive maintenance program and equipment reliability.
• Represent maintenance during FDA ISO audits and customer audits.
• Support nonconformance, CAPA, and change-control processes; develop SOPs.

Skills

Calibration

Metrology

Leadership

FDA QMSR

ISO 13485

Gage R&R

Reading drawings

IQ/OQ

CMMS

Deacom ERP

MS Office

Education

High school diploma or GED

AS degree in electronics or related

ASQ CCT / CQT / ISO/IEC 17025 awareness / OSHA 10/30

Tools

CMMS familiarity

ERP Deacom

MS Office

Job description

Life Science Outsourcing, Inc. in Brea, CA is seeking a Calibration and Maintenance Supervisor to lead two mission-critical programs, drive maintenance and calibration across shifts, and ensure compliance with FDA QMSR and ISO 13485 standards.

You will own programs, supervise technicians, manage records, and collaborate with Quality and Engineering to minimize downtime while maintaining GMP and GDP standards in a fast-paced CMO environment.