Quality Measurement & Calibration Technician

AVNA Inc.
  • New Britain, CT
  • Full-time
16 days ago

Job Description

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

Numbers & Facts

LocationNew Britain, CT
Job TypeFull-time

Skills

  • American Society for Quality (ASQ)unmatched
  • Analysis Skillsunmatched
  • Calibrationunmatched
  • Capability Maturity Model (CMM)unmatched
  • Code of Federal Regulationsunmatched
  • Comparatorunmatched
  • Cross-Functionalunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • EEO Regulationsunmatched
  • Engineering Drawingunmatched
  • External Auditunmatched
  • FDA (Food and Drug Administration)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Internal Auditunmatched
  • Lifting Equipmentunmatched
  • Manufacturingunmatched
  • Manufacturing Auditunmatched
  • Medical Equipmentunmatched
  • Metrologyunmatched
  • Physical Demandsunmatched
  • Procedure Developmentunmatched
  • Quality Engineeringunmatched
  • Quality Metricsunmatched
  • Record Keepingunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Systems Analysisunmatched
  • Team Playerunmatched
  • Test & Measurement Equipmentunmatched
  • Traceabilityunmatched
  • U.S. National Institute of Standards and Technology (NIST)unmatched

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