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:

radiology and imaging systems

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