Quality Control Executive - Vapi - Meril

    Meril
    Meril Vapi

    19 hours ago

    Description

    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
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