Job Title:
Quality Control Engineer – Surgical Robotics.
Department:
Quality Control – Surgical Robotics.
Location:
Vapi, Gujarat.
Reports To:
Manager / Senior Manager – Quality Control.
Job Purpose:
To ensure the quality, safety, and compliance of surgical robotic systems and mechanical assemblies by executing inspection activities, maintaining quality documentation, and supporting regulatory and quality system requirements across incoming, in-process, and final inspection stages.
Key Responsibilities:
1. Inspection & Quality Control Activities
• Perform incoming, in-process, and final inspections of mechanical components, sub-assemblies, and systems used in surgical robotics.
• Plan and execute incoming raw material inspections as per approved engineering drawings, specifications, and inspection plans.
• Conduct visual, dimensional, and functional inspections using standard quality tools and measuring instruments.
• Interpret and verify engineering drawings, tolerances, GD&T, and material specifications.
2. Quality Tools & Non-Conformance Handling
• Identify, document, and report non-conformances (NCRs) in accordance with internal procedures.
• Support deviation handling, root cause analysis, and corrective actions under guidance.
• Ensure effective use and calibration awareness of vernier callipers, micrometres, gauges, and measuring instruments.
3. Documentation & Compliance
• Maintain accurate and compliant quality inspection records, logs, and reports.
• Follow Good Documentation Practices (GDP) and data integrity requirements.
• Ensure adherence to ISO 13485 Medical Device Quality Management System and internal SOPs.
4. Cross-Functional Collaboration
• Work closely with Manufacturing, Engineering, R&D, and Quality Assurance teams to resolve quality issues.
• Support quality inputs during process changes, validations, and continuous improvement initiatives.
• Assist Supplier Quality and Engineering teams with inspection feedback and quality trends.
5. Continuous Improvement & Discipline
• Participate in quality improvement initiatives to enhance inspection effectiveness and product reliability.
• Maintain high standards of discipline, safety, and workplace compliance.
• Demonstrate ownership and accountability in a regulated medical device environment.
Qualifications and Experience:
• Diploma or Degree in Mechanical Engineering.
• Minimum 3 years of experience in Quality Control within medical devices, surgical instruments, surgical robotics, or precision manufacturing.
• Hands-on exposure to inspection processes and quality documentation in regulated industries.
Skills and Competencies:
• Strong understanding of quality control principles and inspection methodologies.
• Ability to read and interpret engineering drawings and specifications.
• Familiarity with ISO 13485 and medical device quality requirements.
• Basic understanding of NCRs, deviations, and corrective actions.
• Proficient in MS Office (Word, Excel, PowerPoint) for documentation and reporting.
• Excellent attention to detail, analytical ability, and observation skills.
• Good communication, teamwork, and coordination skills.
• Willingness to learn and adapt in a global, regulated MedTech environment.
Key Performance Indicators (KPIs):
• Accuracy and timeliness of inspection activities
• Number and quality of NCRs identified and supported for closure
• Compliance with ISO 13485 and internal quality procedures
• Documentation accuracy and audit readiness
• Contribution to quality improvement and reduction of rework or defects
Quality Control Engineer • Vapi, India
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