Imaging Equipment Quality Assurance Specialist

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

Prepare, execute, and maintain documentation for process validation, equipment qualification (IQ / OQ / PQ), and design verification activities.

Maintain and update Device History Records (DHR) and Device Master Records (DMR) as per ISO 13485 requirements.

Review and control documents including SOPs, Work Instructions, Quality Plans, and Validation Protocols.

Ensure traceability and proper control of documents across all production and quality processes.

3. Internal Audits and Compliance

Plan and conduct internal quality audits to verify compliance with ISO 13485, GMP, and regulatory requirements.

Identify non-conformities, issue audit findings, and ensure timely implementation of Corrective and Preventive Actions (CAPA).

Support external audits conducted by certification bodies, notified agencies, or regulatory authorities.

Promote awareness of quality standards and support continuous improvement initiatives across the Radiology Division.

4. Cross-Functional Coordination

Collaborate with Design, Production, QC, and Regulatory Affairs teams to ensure alignment on quality objectives.

Participate in change control, risk management, and product lifecycle reviews to ensure regulatory compliance.

Provide training and guidance to production and testing teams on quality system requirements and documentation practices.

Qualifications and Experience :

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

3–5 years (or more) of experience in Quality Assurance, Validation, or Compliance within medical device or imaging equipment manufacturing.

Strong understanding of ISO 13485, ISO 14971, GMP, and IEC 60601 standards.

Experience with X-Ray, C-Arm, DR, or CT system assemblies preferred.

Knowledge of process validation, equipment qualification, and audit handling is essential.

Skills and Competencies :

In-depth understanding of medical device quality systems and documentation control.

Strong analytical and validation skills with a methodical approach.

Excellent communication, coordination, and reporting abilities.

Proficiency in MS Office, ERP systems, and document management tools.

Attention to detail, process discipline, and a proactive approach to compliance.

Ability to work cross-functionally in a regulated manufacturing environment.

Key Performance Indicators (KPIs) :

Compliance with ISO 13485 and audit requirements

Timely completion of validation and documentation activities

Reduction in non-conformities and audit observations

Accuracy and completeness of quality documentation

Effectiveness of CAPA implementation