Test Engineer QC Radiology

2 days ago

Vapi, Gujarat, India 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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