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Quality Control Executive

Quality Control Executive

MerilVapi, Gujarat, India
2 days ago
Job 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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    Quality Control Executive • Vapi, Gujarat, India

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