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