Quality Assurance Executive

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