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:

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