Quality Control Executive

Job Title:Quality Control Executive – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)Department:Quality Assurance – Radiology DivisionLocation:Vapi, GujaratReports To:Manager / Senior Manager – Quality AssuranceJob 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