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.
- 35 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
