Job Description
Job Title:
Assistant Manager – Quality Assurance.
Department:
Quality Assurance – Surgical Robotics Division.
Location:
Vapi, Gujarat.
Reports To:
Manager – Quality Assurance / Head – Quality.
Job Purpose:
To lead and strengthen the Quality Assurance function for surgical robotic products by ensuring effective implementation of the ISO 13485 Quality Management System, regulatory compliance, robust documentation practices, and proactive quality risk management across manufacturing, inspection, and support processes.
Key Responsibilities:
1. Quality Management System (QMS) Leadership
• Support and drive the implementation, maintenance, and continual improvement of the ISO 13485 QMS for surgical robotics.
• Ensure quality policies, SOPs, and work instructions are effectively implemented and followed across departments.
• Promote a strong quality and compliance culture aligned with patient safety and regulatory expectations.
2. Documentation Control & Compliance Oversight
• Own and oversee quality documentation systems, ensuring compliance with Good Documentation Practices (GDP).
• Review, approve, and control quality documents including SOPs, formats, logs, inspection records, and reports.
• Ensure document traceability, version control, data integrity, and audit readiness at all times.
3. Inspection Oversight & Quality Governance
• Provide QA oversight for incoming, in-process, and final inspection activities.
• Review inspection plans, inspection records, and measurement results for compliance with engineering drawings and specifications.
• Ensure proper planning and execution of incoming raw material inspections in coordination with QC and Supplier Quality teams.
• Verify effective use and calibration awareness of inspection and measuring instruments.
4. Non-Conformance, Deviation & CAPA Management
• Lead and govern the Non-Conformance (NCR) and deviation management process.
• Ensure timely investigation, root cause analysis, risk assessment, and closure of NCRs and deviations.
• Support and monitor Corrective and Preventive Actions (CAPA) for effectiveness and regulatory compliance.
• Escalate critical quality issues with appropriate risk-based decision-making.
5. Audit & Regulatory Readiness
• Lead preparation and support for internal audits, supplier audits, and external regulatory audits (ISO 13485, customer, notified body).
• Act as a key QA representative during audits, ensuring clear communication and effective response to audit observations.
• Ensure timely closure of audit findings and implementation of corrective actions.
6. Cross-Functional Leadership & Collaboration
• Partner with Manufacturing, Engineering, R&D, Supply Chain, and QC teams to embed quality requirements into processes and products.
• Provide QA inputs for process changes, validations, and continuous improvement initiatives.
• Mentor and guide QA Executives and QC team members, building capability and accountability.
7. Continuous Improvement & Risk-Based Thinking
• Drive continuous improvement initiatives focused on defect reduction, process capability, and compliance maturity.
• Apply risk-based thinking to quality decisions and change management.
• Analyze quality trends, metrics, and KPIs to support management reviews and decision-making.
Qualifications and Experience:
• Bachelor’s degree in mechanical/electrical/electronic Engineering or relevant engineering discipline.
• Minimum 5–8 years of progressive experience in Quality Assurance within medical devices, surgical instruments, surgical robotics, or other regulated industries.
• Hands-on experience with ISO 13485 QMS implementation and maintenance.
• Exposure to regulatory audits and inspection readiness activities.
Skills and Competencies:
• Strong understanding of quality control principles, inspection methodologies, and QA systems.
• Ability to read and interpret engineering drawings, tolerances, and specifications.
• Practical knowledge of ISO 13485, GDP, NCR, deviation, and CAPA processes.
• Familiarity with inspection tools and measurement systems (vernier callipers, micrometres, gauges).
• Proficiency in MS Office (Word, Excel, Power Point) and quality documentation tools.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective communication, leadership, and stakeholder management skills.
• High level of discipline, ownership, and attention to detail.
• Ability to operate effectively in a global, regulated Med Tech environment.
Key Performance Indicators (KPIs):
• QMS compliance and audit outcomes
• Timely and effective closure of NCRs, deviations, and CAPAs
• Documentation accuracy, data integrity, and audit readiness
• Reduction in quality issues, rework, and repeat non-conformances
• Effectiveness of cross-functional quality initiatives and team development
Assistant Manager – Quality Assurance.
Department:
Quality Assurance – Surgical Robotics Division.
Location:
Vapi, Gujarat.
Reports To:
Manager – Quality Assurance / Head – Quality.
Job Purpose:
To lead and strengthen the Quality Assurance function for surgical robotic products by ensuring effective implementation of the ISO 13485 Quality Management System, regulatory compliance, robust documentation practices, and proactive quality risk management across manufacturing, inspection, and support processes.
Key Responsibilities:
1. Quality Management System (QMS) Leadership
• Support and drive the implementation, maintenance, and continual improvement of the ISO 13485 QMS for surgical robotics.
• Ensure quality policies, SOPs, and work instructions are effectively implemented and followed across departments.
• Promote a strong quality and compliance culture aligned with patient safety and regulatory expectations.
2. Documentation Control & Compliance Oversight
• Own and oversee quality documentation systems, ensuring compliance with Good Documentation Practices (GDP).
• Review, approve, and control quality documents including SOPs, formats, logs, inspection records, and reports.
• Ensure document traceability, version control, data integrity, and audit readiness at all times.
3. Inspection Oversight & Quality Governance
• Provide QA oversight for incoming, in-process, and final inspection activities.
• Review inspection plans, inspection records, and measurement results for compliance with engineering drawings and specifications.
• Ensure proper planning and execution of incoming raw material inspections in coordination with QC and Supplier Quality teams.
• Verify effective use and calibration awareness of inspection and measuring instruments.
4. Non-Conformance, Deviation & CAPA Management
• Lead and govern the Non-Conformance (NCR) and deviation management process.
• Ensure timely investigation, root cause analysis, risk assessment, and closure of NCRs and deviations.
• Support and monitor Corrective and Preventive Actions (CAPA) for effectiveness and regulatory compliance.
• Escalate critical quality issues with appropriate risk-based decision-making.
5. Audit & Regulatory Readiness
• Lead preparation and support for internal audits, supplier audits, and external regulatory audits (ISO 13485, customer, notified body).
• Act as a key QA representative during audits, ensuring clear communication and effective response to audit observations.
• Ensure timely closure of audit findings and implementation of corrective actions.
6. Cross-Functional Leadership & Collaboration
• Partner with Manufacturing, Engineering, R&D, Supply Chain, and QC teams to embed quality requirements into processes and products.
• Provide QA inputs for process changes, validations, and continuous improvement initiatives.
• Mentor and guide QA Executives and QC team members, building capability and accountability.
7. Continuous Improvement & Risk-Based Thinking
• Drive continuous improvement initiatives focused on defect reduction, process capability, and compliance maturity.
• Apply risk-based thinking to quality decisions and change management.
• Analyze quality trends, metrics, and KPIs to support management reviews and decision-making.
Qualifications and Experience:
• Bachelor’s degree in mechanical/electrical/electronic Engineering or relevant engineering discipline.
• Minimum 5–8 years of progressive experience in Quality Assurance within medical devices, surgical instruments, surgical robotics, or other regulated industries.
• Hands-on experience with ISO 13485 QMS implementation and maintenance.
• Exposure to regulatory audits and inspection readiness activities.
Skills and Competencies:
• Strong understanding of quality control principles, inspection methodologies, and QA systems.
• Ability to read and interpret engineering drawings, tolerances, and specifications.
• Practical knowledge of ISO 13485, GDP, NCR, deviation, and CAPA processes.
• Familiarity with inspection tools and measurement systems (vernier callipers, micrometres, gauges).
• Proficiency in MS Office (Word, Excel, Power Point) and quality documentation tools.
• Strong analytical, problem-solving, and decision-making abilities.
• Effective communication, leadership, and stakeholder management skills.
• High level of discipline, ownership, and attention to detail.
• Ability to operate effectively in a global, regulated Med Tech environment.
Key Performance Indicators (KPIs):
• QMS compliance and audit outcomes
• Timely and effective closure of NCRs, deviations, and CAPAs
• Documentation accuracy, data integrity, and audit readiness
• Reduction in quality issues, rework, and repeat non-conformances
• Effectiveness of cross-functional quality initiatives and team development
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