Test Engineer QC Radiology

2 weeks ago

New Delhi, India Meril Full time

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 SystemsJob Purpose: To perform quality control testing, inspection, and validation ofradiology and imaging systemsincludingX-Ray, C-Arm, Digital Radiography (DR), and CT Scan equipment , ensuring compliance withBIS, ISO, and IEC standardsand maintaining the highest levels of safety, accuracy, and reliability.Key Responsibilities: 1. Product Testing and Inspection Conductelectrical, mechanical, radiation, and functional testingof X-Ray, C-Arm, DR, and CT systems as per approved test procedures and standards as per BIS & IEC. Verify system performance parameters includingelectrical safety, mechanical stability, Mechanical Stability and operational accuracy. Carry outfinal acceptance testingbefore equipment release. Ensure complete adherence toBIS 13450 ,ISO 13485 , andIEC 60601series standards for medical electrical and imaging equipment. 2. Quality Compliance and Documentation Maintain detailed and accuratetesting records, calibration data, and inspection reportsin line with internal and external audit requirements. Ensure strict compliance withGood Manufacturing Practices (GMP)and quality management documentation. Identify non-conformities, assist inroot cause analysis , and implementCorrective 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 arecalibrated, certified, and properly maintained . Perform or support calibration ofHV 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 perBIS, ISO 13485, IEC 60601 , and relatedmedical 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 / DiplomainElectronics, Biomedical. 3–5 years (or more)of experience inQuality Control, Testing, or Validationof radiology or medical imaging equipment. Hands-on experience in testingX-Ray generators, DR detectors, high-voltage assemblies, and imaging control systems. Strong knowledge ofBIS, ISO 13485, GMP, and IEC 60601compliance requirements for medical devices.Skills and Competencies: Proficiency in usingelectrical 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 withhigh-voltage systems, Earth testing, digital imaging detectors, and DICOM standardspreferred. 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

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