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Job Title: QC Testing Engineer – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)

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Department

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Quality Control / Quality Assurance – Radiology Division

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Location

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Vapi, Gujarat

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Reports To

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QC Supervisor / Manager – Radiology Systems

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Job Purpose

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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.

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Key Responsibilities

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- Product Testing and Inspection

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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.

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Verify system performance parameters including electrical safety, mechanical stability, Mechanical Stability and operational accuracy.

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Carry out final acceptance testing before equipment release.

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Ensure complete adherence to BIS 13450 , ISO 13485 , and IEC 60601 series standards for medical electrical and imaging equipment.

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- Quality Compliance and Documentation

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Maintain detailed and accurate testing records, calibration data, and inspection reports in line with internal and external audit requirements.

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Ensure strict compliance with Good Manufacturing Practices (GMP) and quality management documentation.

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Identify non-conformities, assist in root cause analysis , and implement Corrective and Preventive Actions (CAPA).

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Collaborate with R&D;, Production, and QA teams to continuously improve product quality and testing efficiency.

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- Equipment Calibration and Maintenance

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Ensure all testing and measuring instruments are calibrated, certified, and properly maintained .

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Perform or support calibration of HV Tester, NLC Tester, electrical safety analyzers, and mechanical gauges.

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Monitor and maintain environmental, radiation, and electrical safety standards during testing operations.

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- Standards and Regulatory Alignment

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Execute testing as per BIS, ISO 13485, IEC 60601 , and related medical imaging equipment standards.

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Stay updated with new and revised standards for diagnostic imaging systems including DR, X-Ray, and CT equipment.

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Participate in internal and external audits by certification and regulatory authorities.

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Qualifications and Experience

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~ B.E. / B.Tech / Diploma in Electronics, Biomedical.

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~3–5 years (or more) of experience in Quality Control, Testing, or Validation of radiology or medical imaging equipment.

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~ Hands-on experience in testing X-Ray generators, DR detectors, high-voltage assemblies, and imaging control systems.

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~ Strong knowledge of BIS, ISO 13485, GMP, and IEC 60601 compliance requirements for medical devices.

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Skills and Competencies

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Proficiency in using electrical safety analyzers as HV tester, earth tester, NLC tester, and calibration tools.

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Strong analytical and diagnostic skills with attention to detail.

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Excellent documentation, observation, and reporting capabilities.

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Familiarity with high-voltage systems, Earth testing, digital imaging detectors, and DICOM standards preferred.

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Valuable communication, teamwork, and cross-functional coordination skills.

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Commitment to quality, safety, and continuous improvement.

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Key Performance Indicators (KPIs)

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Accuracy and completeness of test reports

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Compliance with BIS / ISO / IEC standards

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Reduction in product rejections and field complaints

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Timely completion of testing activities

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Successful audit outcomes and documentation readiness

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