Test Engineer (Performance testing) (Vapi)

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

- 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.

- 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.

- 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.

- 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.

Valuable 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