Administrator, Calibration & Preventive Maintenance

Job Details

Job Location:

Irvine, CA 92618

Position Type:
Full Time

Education Level: High School

Salary Range: $39.00 - $39.00 Hourly

Job Title:

Administrator, Calibration & Preventive Maintenance

Role Level: Individual Contributor

Supervisor/Manager

Title:

VP of Quality & Compliance

Job Location & Environment:
Irvine, CA – Corporate Office / Laboratory Environment

The Calibration & Preventive Maintenance Administrator is responsible for coordinating, scheduling, documenting, and maintaining the company's calibration and preventive maintenance programs for manufacturing, laboratory, inspection, test, and facility equipment. This role ensures all equipment remains in a qualified state and complies with applicable regulatory requirements including FDA QMSR (21 CFR Part 820), ISO 13485, ISO 17025 (where applicable), EU MDR, and internal Quality Management System procedures.

The position serves as the primary administrator of the calibration database and coordinates activities with Manufacturing, Engineering, Facilities, Quality, Metrology, and external service providers.

• Maintain the master equipment calibration database.
• Schedule calibration activities to ensure 100% on-time completion.
• Generate calibration work orders.
• Coordinate internal and external calibration providers.
• Ensure calibrated equipment is properly identified with current calibration status.
• Review calibration certificates for completeness and compliance.
• Verify traceability to national or international standards (e.g., NIST).
• Ensure calibration records are complete, accurate, and inspection ready.
• Coordinate out-of-tolerance (OOT) equipment evaluations with Quality Engineering.

• Maintain the preventive maintenance master schedule.
• Generate PM work orders.
• Coordinate maintenance activities with equipment owners.
• Track completion of PM activities.
• Ensure maintenance records are complete and filed appropriately.
• Escalate overdue PM activities.
• Coordinate equipment downtime with Manufacturing and Facilities.

• Register new equipment into the calibration/PM system.
• Assign equipment identification numbers.
• Maintain equipment history files.
• Archive retired equipment records.
• Support equipment relocation and decommissioning activities.

• Maintain calibration certificates.
• Maintain PM records.
• Ensure electronic and paper records comply with document control procedures.
• Support audit readiness activities.
• Maintain equipment lists and status reports.

• Schedule third-party calibration vendors.
• Coordinate service contracts.
• Track vendor performance.
• Verify vendor qualifications and certifications.
• Support vendor audits as required.

Prepare and maintain KPIs including:

• Calibration compliance (% on time)
• PM compliance (% on time)
• Overdue equipment
• Equipment downtime
• Vendor turnaround time
• Out-of-tolerance events
• Open work orders
• Equipment inventory status

• A high school degree minimum, Associate degree desired.
• Minimum of 4 years’ experience performing equipment preventative maintenance in a highly regulated industry (Medical, Aerospace, Automotive).
• Familiarity with procedures, equipment and tools used in the medical device industry or other regulated industries.

• Must be able to work effectively and collaborate within cross-functional teams.
• Ability to follow written and verbal instructions.
• Ability to take initiative and able to complete hands-on work.
• Ability to focus on single tasks that require high attention to detail.
• Able to prioritize multiple tasks for efficiency.
• Must be able to perform routine work with minimal supervision.
• Must be able to perform non-routine work with close supervision.
• Must be able to complete the applicable training requirements.
• Must understand GMP procedures and be able to work in a controlled environment (clean room).

• Must be able to frequently stand, walk, bend, stoop, kneel, and climb ladders while performing maintenance and equipment support activities.
• Must be able to lift, carry, push, and pull materials, tools, equipment, and supplies weighing up to 50 pounds without assistance and heavier items with appropriate equipment or assistance.
• Must be able to work in a variety of environments, including office, warehouse, manufacturing, cleanroom, and mechanical equipment areas, while wearing required personal protective equipment (PPE).
• Must be able to perform work in confined spaces, elevated locations, and around mechanical, electrical, and utility systems while following all applicable safety procedures.
• Must possess sufficient visual acuity, manual dexterity, and hand-eye coordination to inspect, troubleshoot, repair, calibrate, and maintain equipment and facility systems.