Quality Control Engineer

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