QC Testing Engineer

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.
• Verify system performance parameters including
  radiation output, image quality, electrical safety, mechanical stability, and operational accuracy.
• Carry out
  pre-dispatch inspection (PDI)
  and
  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
  radiation meters, electrical safety analyzers, imaging test phantoms, 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
  radiation dosimeters, electrical safety analyzers, image quality test phantoms, and calibration tools.
• Strong analytical and diagnostic skills with attention to detail.
• Excellent documentation, observation, and reporting capabilities.
• Familiarity with
  high-voltage systems, 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