Test Engineer QC Radiology

7 hours ago


Vapi Gujarat India, Gujarat Meril Full time

Job Title:

QC Testing Engineer – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)

Department:

Quality Control / Quality Assurance – Radiology Division

Location:

Vapi, Gujarat

Reports To:

QC Supervisor / Manager – Radiology Systems


Job Purpose:

To perform quality control testing, inspection, and validation of radiology and imaging systems including X-Ray, C-Arm, Digital Radiography (DR), and CT Scan equipment, ensuring compliance with BIS, ISO, and IEC standards and maintaining the highest levels of safety, accuracy, and reliability.


Key Responsibilities:

1. Product Testing and Inspection

  • Conduct electrical, mechanical, radiation, and functional testing of X-Ray, C-Arm, DR, and CT systems as per approved test procedures and standards as per BIS & IEC.
  • Verify system performance parameters including electrical safety, mechanical stability, Mechanical Stability and operational accuracy.
  • Carry out final acceptance testing before equipment release.
  • Ensure complete adherence to BIS 13450, ISO 13485, and IEC 60601 series standards for medical electrical and imaging equipment.

2. Quality Compliance and Documentation

  • Maintain detailed and accurate testing records, calibration data, and inspection reports in line with internal and external audit requirements.
  • Ensure strict compliance with Good Manufacturing Practices (GMP) and quality management documentation.
  • Identify non-conformities, assist in root cause analysis, and implement Corrective and Preventive Actions (CAPA).
  • Collaborate with R&D, Production, and QA teams to continuously improve product quality and testing efficiency.

3. Equipment Calibration and Maintenance

  • Ensure all testing and measuring instruments are calibrated, certified, and properly maintained.
  • Perform or support calibration of HV Tester, NLC Tester, electrical safety analyzers, and mechanical gauges.
  • Monitor and maintain environmental, radiation, and electrical safety standards during testing operations.

4. Standards and Regulatory Alignment

  • Execute testing as per BIS, ISO 13485, IEC 60601, and related medical imaging equipment standards.
  • Stay updated with new and revised standards for diagnostic imaging systems including DR, X-Ray, and CT equipment.
  • Participate in internal and external audits by certification and regulatory authorities.


Qualifications and Experience:

  • B.E. / B.Tech / Diploma in Electronics, Biomedical.
  • 3–5 years (or more) of experience in Quality Control, Testing, or Validation of radiology or medical imaging equipment.
  • Hands-on experience in testing X-Ray generators, DR detectors, high-voltage assemblies, and imaging control systems.
  • Strong knowledge of BIS, ISO 13485, GMP, and IEC 60601 compliance requirements for medical devices.


Skills and Competencies:

  • Proficiency in using electrical safety analyzers as HV tester, earth tester, NLC tester, and calibration tools.
  • Strong analytical and diagnostic skills with attention to detail.
  • Excellent documentation, observation, and reporting capabilities.
  • Familiarity with high-voltage systems, Earth testing, digital imaging detectors, and DICOM standards preferred.
  • Good communication, teamwork, and cross-functional coordination skills.
  • Commitment to quality, safety, and continuous improvement.


Key Performance Indicators (KPIs):

  • Accuracy and completeness of test reports
  • Compliance with BIS / ISO / IEC standards
  • Reduction in product rejections and field complaints
  • Timely completion of testing activities
  • Successful audit outcomes and documentation readiness


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