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 requirementsEnsure all equipment is compliant with ISO standardsSupport measurement system analysis (MSA)including Gage R&R studiesIdentify out-of-tolerance conditions and assist with impact assessments and investigationsCoordinate external calibration services and vendors as neededAssist in developing and improving calibration procedures and schedulesMaintain calibration database and ensure proper labeling/status of equipmentSupport internal and external audits (ISO, customer audits)Work cross-functionally with Quality, Engineering, and Manufacturing teamsEnsure compliance with 21 CFR Part 820and ISO 13485requirements
Qualifications
Education & Experience
Associates or Bachelors degree in Engineering, Quality, Metrology, or related field preferred25+ 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 gaugesOptical comparators, CMM (Coordinate Measuring Machines)Force, torque, pressure, and temperature measurement devices
Familiarity with:Measurement System Analysis (MSA)Gage R&RCalibration standards and traceability (NIST preferred)
Experience with calibration management software systemsAbility to read engineering drawings and specifications
Regulatory Knowledge
Understanding of:FDA 21 CFR Part 820ISO 13485Good Documentation Practices (GDP)
Soft Skills
Strong attention to detail and accuracyProblem-solving and analytical thinkingGood documentation and organizational skillsAbility to work independently and in a team environment
Physical Requirements
Ability to work in a manufacturing environmentMay require lifting equipment up to 25 lbsStanding and walking for extended periods
Preferred Qualifications
ASQ Certified Calibration Technician (CCT) or similar certificationExperience in medical device manufacturing environmentExperience supporting audits or regulatory inspections
An Equal Opportunity Employer -----M/F/D/V
