Ajulia Executive Search
Equipment Calibration Manager
Ajulia Executive Search, Chicago, Illinois, United States, 60290
Overview
Are you ready for a leadership role in the manufacturing industry? This opportunity as an Equipment Calibration Manager offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, PTO, etc. Does this position match your future career goals? Then this Equipment Calibration Manager role could be the right fit for you.
Job Summary The Equipment Manager (Calibration & Maintenance) is responsible for the reliability, calibration, and regulatory compliance of all manufacturing, inspection, and test equipment within the X-ray tube production facility. This role leads the preventive maintenance and calibration programs, ensuring equipment performance, accuracy, and uptime meet quality system and regulatory requirements.
Responsibilities As a Equipment Calibration Manager you will:
Ensure compliance with QMS, GMP, EHS, and safety requirements, including proper documentation and recordkeeping.
Follow approved procedures for all controlled processes and maintain a clean, safe work environment.
Manage the site-wide calibration program in compliance with ISO 13485, FDA 21 CFR 820, IEC 60601, and ISO 17025/NIST traceability.
Maintain equipment master lists, calibration schedules, and records; investigate out‑of‑tolerance conditions.
Own the preventive and corrective maintenance programs for all production and test equipment.
Plan and schedule maintenance activities to minimize production downtime.
Lead equipment troubleshooting, root cause analysis, and corrective actions.
Oversee equipment qualification (IQ/OQ/PQ) and full equipment lifecycle management.
Maintain equipment documentation, inventory records, and change control.
Manage spare parts inventory, vendors, contractors, and equipment purchases.
Supervise and train maintenance and calibration technicians and production staff.
Promote a culture of safety, reliability, and continuous improvement.
Maintain audit readiness and support internal, customer, and regulatory audits.
Support EHS programs, including lockout/tagout, radiation safety, and high‑voltage systems.
Skills and Requirements
5+ years of experience in equipment maintenance, calibration, or reliability management within a medical device or high‑tech manufacturing environment; X‑ray, vacuum, or semiconductor experience preferred.
Proven experience managing calibration systems compliant with ISO 13485 and FDA 21 CFR Part 820.
Strong working knowledge of vacuum systems, high‑voltage test equipment, and radiation safety practices.
Solid understanding of measurement system analysis (MSA) and calibration uncertainty.
Proficiency with CMMS or calibration management software such as MP2 or Fluke eMaint.
Strong analytical, diagnostic, and troubleshooting skills.
Effective communication and documentation abilities.
Education
Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering, or equivalent technical discipline.
Advanced training in metrology, reliability engineering, or equipment management preferred.
Benefits
401(k)
401(k) matchingDental insurance
Flexible spending account
Health insurance
Paid time off
Vision insurance
Salary Range Pay: $85K - $95K
Contact Ask for: Hersha Dwyer
#J-18808-Ljbffr
Job Summary The Equipment Manager (Calibration & Maintenance) is responsible for the reliability, calibration, and regulatory compliance of all manufacturing, inspection, and test equipment within the X-ray tube production facility. This role leads the preventive maintenance and calibration programs, ensuring equipment performance, accuracy, and uptime meet quality system and regulatory requirements.
Responsibilities As a Equipment Calibration Manager you will:
Ensure compliance with QMS, GMP, EHS, and safety requirements, including proper documentation and recordkeeping.
Follow approved procedures for all controlled processes and maintain a clean, safe work environment.
Manage the site-wide calibration program in compliance with ISO 13485, FDA 21 CFR 820, IEC 60601, and ISO 17025/NIST traceability.
Maintain equipment master lists, calibration schedules, and records; investigate out‑of‑tolerance conditions.
Own the preventive and corrective maintenance programs for all production and test equipment.
Plan and schedule maintenance activities to minimize production downtime.
Lead equipment troubleshooting, root cause analysis, and corrective actions.
Oversee equipment qualification (IQ/OQ/PQ) and full equipment lifecycle management.
Maintain equipment documentation, inventory records, and change control.
Manage spare parts inventory, vendors, contractors, and equipment purchases.
Supervise and train maintenance and calibration technicians and production staff.
Promote a culture of safety, reliability, and continuous improvement.
Maintain audit readiness and support internal, customer, and regulatory audits.
Support EHS programs, including lockout/tagout, radiation safety, and high‑voltage systems.
Skills and Requirements
5+ years of experience in equipment maintenance, calibration, or reliability management within a medical device or high‑tech manufacturing environment; X‑ray, vacuum, or semiconductor experience preferred.
Proven experience managing calibration systems compliant with ISO 13485 and FDA 21 CFR Part 820.
Strong working knowledge of vacuum systems, high‑voltage test equipment, and radiation safety practices.
Solid understanding of measurement system analysis (MSA) and calibration uncertainty.
Proficiency with CMMS or calibration management software such as MP2 or Fluke eMaint.
Strong analytical, diagnostic, and troubleshooting skills.
Effective communication and documentation abilities.
Education
Bachelor’s degree in Mechanical, Electrical, or Industrial Engineering, or equivalent technical discipline.
Advanced training in metrology, reliability engineering, or equipment management preferred.
Benefits
401(k)
401(k) matchingDental insurance
Flexible spending account
Health insurance
Paid time off
Vision insurance
Salary Range Pay: $85K - $95K
Contact Ask for: Hersha Dwyer
#J-18808-Ljbffr