Job Title

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, PowerPoint).• Good communication skills, teamwork, and disciplined working approach.• Willingness to learn and grow in a regulated global MedTech 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