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 AssuranceJob Purpose: To ensure product and process compliance in the manufacturing ofradiology and imaging systemsincludingX-Ray, C-Arm, Digital Radiography (DR), and CT equipment , by validating product quality, managing documentation, and supporting audits as perISO 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 perISO 13485, BIS 13450, and IEC 60601standards. Review and approve quality control data, test results, and inspection reports before product release. Coordinate with theProduction and QC Testing teamsto ensure timely resolution of non-conformities. 2. Process Validation and Documentation Prepare, execute, and maintain documentation forprocess validation, equipment qualification (IQ/OQ/PQ), and design verification activities. Maintain and updateDevice History Records (DHR)andDevice Master Records (DMR)as per ISO 13485 requirements. Review and control documents includingSOPs, 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 conductinternal quality auditsto verify compliance withISO 13485, GMP, and regulatory requirements. Identify non-conformities, issue audit findings, and ensure timely implementation ofCorrective 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 withDesign, Production, QC, and Regulatory Affairsteams 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 / DiplomainElectronics, Biomedical. 3–5 years (or more)of experience inQuality Assurance, Validation, or Compliancewithinmedical device or imaging equipment manufacturing. Strong understanding ofISO 13485, ISO 14971, GMP, and IEC 60601standards. Experience withX-Ray, C-Arm, DR, or CT systemassemblies preferred. Knowledge ofprocess validation, equipment qualification, and audit handlingis essential.Skills and Competencies: In-depth understanding ofmedical device quality systems and documentation control. Strong analytical and validation skills with a methodical approach. Excellent communication, coordination, and reporting abilities. Proficiency inMS 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

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