Radiology Equipment Validation Engineer

Job Title :

Quality Control Executive – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)

Department :

Quality Assurance – Radiology Division

Location : Vapi, Gujarat

Reports To :

Manager / Senior Manager – Quality Assurance

Job Purpose :

To ensure product and process compliance in the manufacturing of radiology and imaging systems including X-Ray, C-Arm, Digital Radiography (DR), and CT equipment , by validating product quality, managing documentation, and supporting audits as per ISO 13485, BIS, and regulatory requirements.

Key Responsibilities :

1. Product Quality Validation

• Validate the quality and performance of X-Ray, C-Arm, DR, and CT assemblies during in-process and final inspection stages.
• Ensure all products meet design, safety, and performance specifications as per ISO 13485, BIS 13450, and IEC 60601 standards.
• Review and approve quality control data, test results, and inspection reports before product release.
• Coordinate with the Production and QC Testing teams to ensure timely resolution of non-conformities.

2. Process Validation and Documentation

3. Internal Audits and Compliance

4. Cross-Functional Coordination

Qualifications and Experience :

Skills and Competencies :

Key Performance Indicators (KPIs) :