Calibration Supervisor
3 hours ago
Brea, CA, United States
Life Science Outsourcing
Full-time
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Job Details: Level: Experienced | Job Location: Corporate Office LSO West - Brea, CA 92821 | Salary Range: $80,000.00 - $90,000.00 Salary/year
Keep the Instruments Trusted and the Equipment Running
What You'll Do
As the Calibration and Maintenance Supervisor, you will own two mission-critical programs and lead the team that executes them every day.
Team Leadership and Development
- 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.
Calibration Program Ownership
- 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.
Preventive Maintenance and Equipment Reliability
- 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.
Qualification, Validation, and Regulatory Readiness
- 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.
Safety Leadership
- 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
Skills and Experience
- 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, gauge 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.
Mindset and Impact
- 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.
Why Join LSO?
- Work where your precision matters: LSO products reach patients who depend on them.
- Lead a specialized team with real ownership of two mission‑critical programs.
- Gain deep experience in FDA‑regulated, ISO 13485‑certified manufacturing.
- Collaborate across Operations, Quality, and Engineering in a high‑performance CMO environment.
- Grow in