QC Testing Engineer - X-Ray / C-Arm / DR / CT

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:

radiology and imaging systems

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