Calibration & Maintenance Supervisor

About the Role

Life Science Outsourcing (LSO) is a contract manufacturer of medical devices in Brea, California. The Calibration and Maintenance Supervisor owns two mission-critical programs: the calibration program and the preventive maintenance program. This role leads a team of technicians, ensures equipment reliability, maintains regulatory compliance, and represents the function during FDA inspections and audits.

What You'll Do

• Supervise, schedule, and develop a team of facility maintenance and calibration technicians across shifts
• Coach technicians, provide ongoing performance feedback, and partner with HR on hiring, onboarding, and corrective action
• Set team metrics — PM completion rate, calibration on-time percentage, equipment downtime, and response time — and drive continuous improvement against each target
• Own the full calibration program: master schedule, calibration intervals, NIST-traceable reference standards, and out-of-tolerance (OOT) investigations including impact and use assessments on affected product
• Perform hands-on calibration as needed and maintain all records in LSO's Electronic Quality Management System
• Uphold ALCOA+ data integrity principles and Good Documentation Practices (GDP) across all calibration records
• Own the preventive maintenance program: PM schedules, work orders, and equipment reliability for facility and production equipment
• Troubleshoot and repair equipment to minimize unplanned downtime
• Manage spare-parts inventory and outside service providers and calibration labs; provide input to the maintenance budget, service contracts, and capital equipment requests
• Oversee IQ and OQ protocols; support equipment commissioning, PQ, and process validation activities
• Monitor and document controlled environment parameters — temperature, humidity, pressure differential, and particle counts — for cleanroom and controlled areas
• Represent the maintenance and calibration function during FDA inspections, ISO 13485 audits, and customer or notified-body audits
• Support nonconformance, CAPA, and change-control processes; develop and maintain SOPs for this business unit
• Champion a safe work environment for the team, owning adherence to lockout/tagout, OSHA and Cal/OSHA requirements, and LSO EHS procedures
• Ensure all team members wear appropriate PPE for each task and work area

Qualifications

• 5 to 7 years of calibration, metrology, and/or preventive maintenance experience — preferably in an FDA-regulated medical device, pharmaceutical, or other regulated manufacturing environment
• At least 2 to 3 years in a lead or supervisory capacity, directing the work of other technicians
• Working knowledge of FDA QMSR (21 CFR Part 820) and ISO 13485:2016
• Metrology fundamentals: NIST traceability, calibration intervals, measurement uncertainty, gage R&R/MSA, and ANSI/NCSL Z540
• Proficiency reading mechanical and electrical drawings, schematics, and equipment manuals; hands-on skill with calibration instruments (gage blocks, calipers, micrometers, multimeters, pressure gauges, thermocouples/RTDs, torque testers)
• Familiarity with calibration management software or CMMS; computer literacy including ERP (Deacom) and Microsoft Office
• Hands-on experience executing IQ/OQ and equipment qualification activities
• High school diploma or GED required; associate degree or technical certificate in electronics, instrumentation, mechatronics, industrial maintenance, or related discipline preferred
• ASQ CCT preferred; CQT, ISO/IEC 17025 awareness, and OSHA 10/30 are a plus

Work Environment

• Full-time, on-site at LSO's Brea, CA facility
• Work occurs on the manufacturing floor and in controlled and cleanroom environments requiring gowning
• May involve work in confined or elevated spaces and the use of hand and power tools
• Frequent use of hands and fingers to handle tools, instruments, and controls
• Regularly lifts and/or moves up to 25 pounds; occasionally up to 50 pounds
• Must be able to sit or stand for extended periods, walk up and down stairs repeatedly, and walk extended distances
• PPE required appropriate to task and area; OSHA and Cal/OSHA requirements apply