Quality Measurement & Calibration Technician

Job Title:

Quality Measurement & Calibration Technician

Position Summary

The Quality Measurement & Calibration Technician is responsible for ensuring the accuracy, reliability, and traceability of measurement and test equipment used in the manufacturing of medical devices. This role supports compliance with regulatory standards and internal quality systems by performing calibration, maintaining records, and assisting with measurement system analysis.

Key Responsibilities

• Perform calibration, verification, and maintenanceof inspection, measuring, and test equipment (IMTE)
• Maintain and update calibration records in accordance with quality system requirements
• Ensure all equipment is compliant with ISO standards
• Support measurement system analysis (MSA)including Gage R&R studies
• Identify out-of-tolerance conditions and assist with impact assessments and investigations
• Coordinate external calibration services and vendors as needed
• Assist in developing and improving calibration procedures and schedules
• Maintain calibration database and ensure proper labeling/status of equipment
• Support internal and external audits (ISO, customer audits)
• Work cross-functionally with Quality, Engineering, and Manufacturing teams
• Ensure compliance with 21 CFR Part 820and ISO 13485requirements

Qualifications

Education & Experience

• Associate's or Bachelor's degree in Engineering, Quality, Metrology, or related field preferred
• 2-5+ years of experience in calibration, metrology, or quality within a regulated industry (medical device preferred)

Technical Skills

• Experience with calibration of tools such as:
• • Calipers, micrometers, height gauges
  • Optical comparators, CMM (Coordinate Measuring Machines)
  • Force, torque, pressure, and temperature measurement devices
  
  
• Familiarity with:
• • Measurement System Analysis (MSA)
  • Gage R&R
  • Calibration standards and traceability (NIST preferred)
  
  
• Experience with calibration management software systems
• Ability to read engineering drawings and specifications

Regulatory Knowledge

• Understanding of:
• • FDA 21 CFR Part 820
  • ISO 13485
  • Good Documentation Practices (GDP)
  
  

Soft Skills

• Strong attention to detail and accuracy
• Problem-solving and analytical thinking
• Good documentation and organizational skills
• Ability to work independently and in a team environment

Physical Requirements

• Ability to work in a manufacturing environment
• May require lifting equipment up to 25 lbs
• Standing and walking for extended periods

Preferred Qualifications

• ASQ Certified Calibration Technician (CCT) or similar certification
• Experience in medical device manufacturing environment
• Experience supporting audits or regulatory inspections

An Equal Opportunity Employer -----M/F/D/V