Quality Control Executive

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