Job Description
Job Title:
QA Executive – Surgical Robotics.
Department:
Quality Assurance – Surgical Robotics Division.
Location:
Vapi, Gujarat.
Reports To:
Manager / Senior Manager – Quality Assurance.
Job Purpose:
To support the Quality Assurance system for surgical robotic products by ensuring compliance with ISO 13485, internal SOPs, and regulatory requirements through documentation control, process adherence, non-conformance handling, and coordination with cross-functional teams.
Key Responsibilities:
1. Quality System & Compliance Support
• Support implementation and maintenance of the Quality Management System (QMS) in line with ISO 13485 requirements.
• Ensure adherence to quality procedures, work instructions, and regulatory standards across manufacturing and inspection activities.
• Promote quality awareness and compliance culture across departments.
2. Documentation & Records Management
• Maintain and control quality-related documents and records in compliance with Good Documentation Practices (GDP).
• Support preparation, review, and archival of quality documents such as SOPs, formats, logs, and reports.
• Ensure document traceability, version control, and audit readiness.
3. Inspection & Quality Oversight
• Support incoming, in-process, and final inspection activities from a QA oversight perspective.
• Review inspection records and ensure compliance with engineering drawings and quality requirements.
• Coordinate with QC teams for raw material inspection planning and execution.
4. Non-Conformance & Deviation Handling
• Assist in documentation and tracking of Non-Conformance Reports (NCRs) and deviations.
• Support root cause analysis and follow-up of corrective and preventive actions (CAPA) under supervision.
• Ensure timely closure and proper documentation of quality issues.
5. Cross-Functional Coordination
• Coordinate with Quality Control, Manufacturing, Engineering, and R&D teams to ensure quality requirements are met.
• Support internal audits, inspections, and quality reviews.
• Assist in continuous improvement initiatives related to quality processes and documentation.
Qualifications and Experience:
• Degree in Mechanical/Electrical/ Electronic Engineering (or relevant engineering discipline).
• 1–3 years of experience in Quality Assurance or Quality Control within medical devices, surgical instruments, surgical robotics, or regulated manufacturing environments.
• Exposure to medical device quality systems is preferred.
Skills and Competencies:
• Basic understanding of quality control principles and inspection processes.
• Strong attention to detail, observation, and analytical skills.
• Ability to read and interpret engineering drawings.
• Familiarity with inspection tools such as vernier callipers, micrometres, gauges, and measuring instruments.
• Basic awareness of ISO 13485 – Medical Device QMS.
• Understanding of Good Documentation Practices (GDP).
• Basic knowledge of NCRs, deviations, and CAPA concepts.
• Proficiency in MS Office (Word, Excel, Power Point).
• Good communication skills, teamwork, and disciplined working approach.
• Willingness to learn and grow in a regulated global Med Tech environment.
Key Performance Indicators (KPIs):
• Accuracy and completeness of QA documentation
• Compliance with ISO 13485 and internal SOPs
• Timely tracking and closure of NCRs and deviations
• Audit readiness and documentation accuracy
• Effective coordination with QC and cross-functional teams
QA Executive – Surgical Robotics.
Department:
Quality Assurance – Surgical Robotics Division.
Location:
Vapi, Gujarat.
Reports To:
Manager / Senior Manager – Quality Assurance.
Job Purpose:
To support the Quality Assurance system for surgical robotic products by ensuring compliance with ISO 13485, internal SOPs, and regulatory requirements through documentation control, process adherence, non-conformance handling, and coordination with cross-functional teams.
Key Responsibilities:
1. Quality System & Compliance Support
• Support implementation and maintenance of the Quality Management System (QMS) in line with ISO 13485 requirements.
• Ensure adherence to quality procedures, work instructions, and regulatory standards across manufacturing and inspection activities.
• Promote quality awareness and compliance culture across departments.
2. Documentation & Records Management
• Maintain and control quality-related documents and records in compliance with Good Documentation Practices (GDP).
• Support preparation, review, and archival of quality documents such as SOPs, formats, logs, and reports.
• Ensure document traceability, version control, and audit readiness.
3. Inspection & Quality Oversight
• Support incoming, in-process, and final inspection activities from a QA oversight perspective.
• Review inspection records and ensure compliance with engineering drawings and quality requirements.
• Coordinate with QC teams for raw material inspection planning and execution.
4. Non-Conformance & Deviation Handling
• Assist in documentation and tracking of Non-Conformance Reports (NCRs) and deviations.
• Support root cause analysis and follow-up of corrective and preventive actions (CAPA) under supervision.
• Ensure timely closure and proper documentation of quality issues.
5. Cross-Functional Coordination
• Coordinate with Quality Control, Manufacturing, Engineering, and R&D teams to ensure quality requirements are met.
• Support internal audits, inspections, and quality reviews.
• Assist in continuous improvement initiatives related to quality processes and documentation.
Qualifications and Experience:
• Degree in Mechanical/Electrical/ Electronic Engineering (or relevant engineering discipline).
• 1–3 years of experience in Quality Assurance or Quality Control within medical devices, surgical instruments, surgical robotics, or regulated manufacturing environments.
• Exposure to medical device quality systems is preferred.
Skills and Competencies:
• Basic understanding of quality control principles and inspection processes.
• Strong attention to detail, observation, and analytical skills.
• Ability to read and interpret engineering drawings.
• Familiarity with inspection tools such as vernier callipers, micrometres, gauges, and measuring instruments.
• Basic awareness of ISO 13485 – Medical Device QMS.
• Understanding of Good Documentation Practices (GDP).
• Basic knowledge of NCRs, deviations, and CAPA concepts.
• Proficiency in MS Office (Word, Excel, Power Point).
• Good communication skills, teamwork, and disciplined working approach.
• Willingness to learn and grow in a regulated global Med Tech environment.
Key Performance Indicators (KPIs):
• Accuracy and completeness of QA documentation
• Compliance with ISO 13485 and internal SOPs
• Timely tracking and closure of NCRs and deviations
• Audit readiness and documentation accuracy
• Effective coordination with QC and cross-functional teams
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