Test Engineer QC Radiology

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