▷ [High Salary] 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