Calibration & Maintenance Supervisor

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

Company Description

(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (LSO) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping.

Keep the Instruments Trusted and the Equipment Running

At Life Science Outsourcing (LSO), precision is not a preference, it is a requirement. We manufacture life-changing medical devices for patients who depend on every measurement being right, every piece of equipment performing as qualified, and every controlled environment staying within spec. The Calibration and Maintenance Supervisor is the person who makes that happen.

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.

What You Bring

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, 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.

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 a PE-backed company with dual U.S. sites and expanding capabilities.

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.

Make an Impact

Every calibrated instrument, every qualified piece of equipment, and every documented PM completed on time is a commitment to the patients who will eventually depend on what LSO builds. As Calibration and Maintenance Supervisor, you are not just keeping the lights on — you are protecting the integrity of the entire manufacturing process. If you are ready to lead a team that takes that responsibility seriously, we want to hear from you.

Additional Information

All your information will be kept confidential according to EEO guidelines.