Company Overview
Chronos Imaging is a leading manufacturer of CT replacement tubes, with over 30 years of dedicated experience in producing high-quality, standards-compliant, and cost-effective solutions. Our commitment to excellence and innovation positions us at the forefront of the medical device industry, delivering reliable products and exceptional service to our customers worldwide.
Job Summary
We are seeking a highly skilled Equipment Calibration Manager to oversee and coordinate calibration activities across our manufacturing and maintenance operations. The ideal candidate will possess extensive technical expertise in industrial maintenance, electrical systems, and precision measurement instruments. As the Equipment Calibration Manager, you will ensure all equipment operates within specified tolerances, maintain calibration schedules, and uphold the highest standards of quality assurance. This role offers an exciting opportunity to lead calibration initiatives that directly impact product reliability and manufacturing efficiency.
The Equipment Manager (Calibration & Maintenance) is responsible for ensuring that all manufacturing, inspection, and test equipment within the X-ray tube production facility are properly maintained, calibrated, and compliant with applicable regulatory and quality system requirements. This role oversees the preventive maintenance and calibration program, manages service technicians, interfaces with metrology labs and equipment OEMs, and supports continuous improvement in equipment reliability and process capability. The Manager will also manage the purchasing, tracking, and maintenance of all equipment, as well as create and implement policies and procedures to ensure efficient operation.
Key Responsibilities/Duties:
- Compliance with the Quality Management System and Environmental, Health & Safety requirements including being responsible for quality of work, good documentation practices/recordkeeping, good manufacturing practices (GMP) and safety.
- For controlled processes, follow the current version of procedures and forms to perform work
- Maintain a clean, safe, and order work area/equipment
- Other tasks and duties as assigned
Job Specific Duties:
1. Calibration Program Management
- Develop, implement, and maintain the site-wide calibration management system in compliance with ISO 13485, FDA 21 CFR Part 820, and IEC 60601-related standards.
- Maintain equipment master lists, calibration records, and certificates for all measuring, inspection, and process monitoring devices.
- Coordinate internal and external calibration activities and ensure timely scheduling to prevent overdue equipment.
- Manage calibration traceability to NIST, ISO17025 as required, or equivalent international standards.
- Support calibration data review and investigate out-of-tolerance (OOT) conditions and their potential impact on product quality.
2. Preventive & Corrective Maintenance
- Own the preventive maintenance (PM) program for all production and test equipment, including vacuum furnaces, high-voltage test stands, helium leak detectors, vacuum pumps, and alignment fixtures.
- Plan and schedule PM tasks, ensuring minimal disruption to production.
- Lead troubleshooting and root cause analysis of equipment failures; coordinate corrective actions and equipment upgrades.
- Maintain spare parts inventory and ensure availability of critical spares for key systems.
3. Equipment Qualification & Lifecycle Management
- Oversee equipment qualification (IQ/OQ/PQ) activities for new installations, transfers, or process changes.
- Collaborate with Process Engineering and Quality teams to define critical parameters and acceptance criteria.
- Manage the full equipment lifecycle—from acquisition, validation, and operation through decommissioning and disposal.
- Maintain up-to-date equipment documentation, manuals, and change control records.
- Monitor and update equipment inventory records
- Purchase new equipment and supplies as needed
- Track and maintain all equipment maintenance and calibration records
- Develop and implement policies and procedures for efficient equipment operation
- Conduct regular equipment inspections to ensure safety and compliance with standards
- Ensure that all equipment is in good working condition
- Troubleshoot any problems that arise with equipment
- Operate and maintain equipment
- Coordinate with vendors and contractors to perform routine maintenance
- Make recommendations for new or replacement equipment
- Develop and manage budgets for purchasing and maintenance
- Train staff in the proper use of equipment
4. Team Leadership & Training
- Supervise calibration and maintenance technicians, providing technical direction, workload planning, and performance feedback.
- Train production and test personnel in proper equipment use, basic maintenance, and safety practices.
- Promote a culture of reliability, safety, and continuous improvement across the equipment maintenance function.
5. Compliance & Audit Readiness
- Ensure readiness for internal, customer, and regulatory audits by maintaining complete, organized, and retrievable calibration and maintenance records.
- Collaborate with QA/RA to respond to audit findings and implement corrective actions.
- Support EHS compliance, including lockout/tagout, radiation safety, and high-voltage system controls.
Competencies & Qualifications:
Education:
- Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering, or equivalent technical discipline.
- Advanced training in metrology, reliability engineering, or equipment management preferred.
Experience:
- 5+ years in equipment maintenance, calibration, or reliability management in a medical device or high-tech manufacturing environment (preferably X-ray, vacuum, or semiconductor industry).
- Experience managing ISO 13485 and 21 CFR 820 compliant calibration systems.
- Familiarity with vacuum systems, high-voltage test equipment, and radiation safety systems is highly desirable.
- Strong understanding of measurement system analysis (MSA) and calibration uncertainty.
Skills:
- Proficient in CMMS or calibration software (MP2, Fluke eMaint)
- Strong analytical and troubleshooting abilities.
- Excellent communication and documentation skills.
- Leadership and project management capability in a cross-functional environment.
Pay: $85,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Application Question(s):
- How many years experience do you have in equipment maintenance, calibration, or reliability management in a medical device or high-tech manufacturing environment?
- Do you have experience managing ISO 13485 and 21 CFR 820 compliant calibration systems?
- Do you have familiarity with vacuum systems, high-voltage test equipment, and radiation safety systems?
- Do you have experience with measurement system analysis (MSA) and calibration uncertainty?
Work Location: In person
