Quality Control Engineer

Meril; Vapi; On-site; INR 400,000 - 600,000; Full time

Job summary

A medical technology company in Vapi, India is hiring a Quality Control Engineer to ensure the quality and compliance of surgical robotic systems. The position requires a Diploma or Degree in Mechanical Engineering and at least 3 years of experience in Quality Control within regulated industries. Responsibilities include performing inspections, documenting non-conformances, and collaborating with cross-functional teams on quality improvement initiatives. The ideal candidate should possess strong quality control principles and analytical skills.

Qualifications

• Minimum 3 years of experience in Quality Control within medical devices, surgical instruments, or precision manufacturing.
• Hands-on exposure to inspection processes and quality documentation in regulated industries.

Responsibilities

• Perform incoming, in-process, and final inspections of mechanical components used in surgical robotics.
• Identify, document, and report non-conformances (NCRs).
• Maintain accurate quality inspection records and follow Good Documentation Practices.
• Collaborate with Manufacturing and Engineering teams to resolve quality issues.

Skills

Quality control principles

Reading engineering drawings

ISO 13485 understanding

NCR handling

MS Office proficiency

Attention to detail

Communication skills

Teamwork

Education

Diploma or Degree in Mechanical Engineering

Job description

Quality Control Engineer – Surgical Robotics.

Department:

Quality Control – Surgical Robotics.

Location:

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.
• 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.