Quality Control Executive

1 day ago

Vapi, Gujarat, India Meril Full time ₹ 5,00,000 - ₹ 12,00,000 per year

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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