Calibration & Maintenance Supervisor

Life Science Outsourcing, Inc.•Brea, CA

6d•$80,000 - $90,000•Onsite

About The Position

Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions. The Calibration and Maintenance Supervisor is responsible for owning two mission-critical programs: calibration and preventive maintenance, and leading the team that executes them. This role involves supervising, scheduling, and developing a team of technicians, owning the full calibration program including master schedule, intervals, NIST-traceable reference standards, and OOT investigations. It also includes owning the preventive maintenance program, troubleshooting and repairing equipment, managing spare parts inventory, and overseeing IQ/OQ protocols. The supervisor will also monitor controlled environment parameters, represent the maintenance and calibration function during audits and inspections, and champion a safe work environment. The role requires a strong understanding of FDA QMSR and ISO 13485:2016, metrology fundamentals, and the ability to lead with accountability and communicate with precision.

Requirements

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.
You take ownership of a program — not just tasks. When something is off, you find out why and fix the root cause.
You lead with accountability, setting clear expectations for your team and modeling the standard yourself.
You communicate with precision: your records are complete, your reports are clear, and you can speak to your function's performance in any meeting.
You stay current with regulatory requirements and treat audit readiness as a baseline, not a sprint.

Nice To Haves

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.

Responsibilities

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 (Grand Ave.).
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.