Calibration & Maintenance Supervisor
Job Summary
What Youll 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 LSOs 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 :
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 functions 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 LSOs 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.
Remote Work :
No
Employment Type :
Full-time
About Company
(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 a ... View more