<p>Job Title: - GM- Quality Assurance (Medical devices)    </p><p>Job Description</p><p> </p><p>The General Manager – The Quality Assurance Manager is responsible for overseeing quality systems and manufacturing quality for PCB assembly, sub-assembly, and final medical device assembly. The role ensures that products are manufactured in compliance with applicable quality standards, regulatory requirements, and customer specifications, while maintaining a robust Quality Management System aligned with ISO 13485 and regulatory requirements from authorities such as Central Drugs Standard Control Organization and U.S. Food and Drug Administration, 21 CFR Part 820.</p><p> </p><p>Roles & Responsibility</p><p>Quality Assurance & Quality Management System</p><p> </p><ul><li>Maintain and improve the Quality Management System in compliance with ISO 13485.</li><li>Ensure adherence to quality procedures, SOPs, and documentation across manufacturing operations.</li><li>Ensure compliance with applicable regulatory requirements including 21 CFR Part 820. and EU Medical Device Regulation where applicable.</li><li>Oversee document control, change control, and training system. Also maintain quality policies, procedures, and documentation.</li><li>Ensure data integrity, documentation control, and record retention.</li><li>Design transfer and New Product Introduction (NPI) quality readiness.</li><li>Data integrity and documentation governance aligned with FDA expectations.</li><li>Prepare quality metrics and reports for management review meetings.</li><li>Monitor KPIs such as complaints, CAPA closure, non-conformance rates, and audit outcomes.</li><li>Review and approve MIS reports and present quality/regulatory updates to leadership.</li><li>Coordinate with Production, QC, R&D, Supply Chain, and Materials departments.</li></ul><p> </p><p>Regulatory Compliance</p><ul><li>Ensure manufacturing operations comply with regulatory requirements from authorities such as U.S. Food and Drug Administration, Central Drugs Standard Control Organization, and global regulatory bodies.</li><li>Support regulatory submissions and product registrations.</li><li>Monitor regulatory updates and implement changes in the QMS.</li></ul><p> </p><p>Quality Control Oversight</p><ul><li>Oversee incoming, in-process and final product inspections.</li><li>Ensure appropriate test methods, acceptance criteria, and quality standards are followed.</li><li>Approve product release as per defined procedures.</li></ul><p> </p><p>Audits & Inspections</p><ul><li>Lead and manage external audits (ISO, Auditing bodies, customers, clients)</li><li>Ensure timely closure of audit non-conformities (NCs)</li><li>Plan and execute internal audits across all departments at defined intervals</li><li>Ensure full compliance with laws, regulations, SOPs, and industry guidelines</li></ul><p> </p><p> </p><p> </p><p>Supplier Quality Management</p><ul><li>Qualify and monitor suppliers.</li><li>Conduct supplier audits and supplier performance reviews.</li><li>Ensure incoming materials meet specifications.</li></ul><p> </p><p>Required Certifications</p><p>Demonstrated expertise and/or formal training in relevant standards and quality systems as below</p><ul><li>ISO 13485:2016 Certified Lead / Internal Auditor</li><li>GMP Certification</li><li>ISO 14971 Risk Management Training</li><li>CAPA & Root Cause Analysis Certification</li></ul><h3>experience</h3>15

<br /><p>1. Strategic Quality Leadership </p><p>• Define and drive the Quality & Process Excellence vision for aligning it with the institution's  strategic objectives and company</p><p>• Institutionalize process frameworks and quality management systems across academic, operational, and administrative functions. </p><p>• Lead organization-wide continuous improvement initiatives using structured methodologies (Lean, Six  Sigma, TQM, or equivalent). </p><p>• Champion a culture of quality and accountability at all levels, from frontline operations to senior leadership. • Provide strategic inputs to the leadership team on quality trends, risks, and improvement roadmaps. </p><p>2. Quality Ecosystem & Governance Engagement </p><p>• Build and manage a robust quality governance structure, including internal audit mechanisms, review  cadences, and escalation protocols. </p><p>• Collaborate with internal teams, external auditors, accreditation bodies, and regulatory agencies to ensure  sustained adherence to quality frameworks. </p><p>• Engage with industry partners, skill councils, and certification bodies to benchmark institutional quality  practices. </p><p>• Oversee end-to-end audit management — from planning and execution to CAPA (Corrective and Preventive  Action) closure. </p><p>• Maintain comprehensive documentation of quality processes, audit trails, governance records, and  improvement logs. </p><p>3. Quality Standards & Compliance Alignment </p><p>• Align organizational processes with relevant international quality standards (e.g., ISO 9001, NAAC  frameworks, or sector-specific quality benchmarks). </p><p>• Ensure consistent process adherence across all campuses and functional verticals, maintaining audit  readiness at all times.</p><p>• Develop and enforce Standard Operating Procedures (SOPs), quality manuals, and compliance checklists. • Monitor regulatory and statutory compliance requirements and proactively address gaps. • Lead institutional preparation for external accreditation, certification, and quality rating processes. </p><p>4. Operational Excellence & Cost Optimization </p><p>• Drive process efficiency and productivity improvements across operations through structured quality and  process re-engineering initiatives. </p><p>• Identify cost optimization opportunities through waste reduction, process standardization, and resource  utilization analysis. </p><p>• Implement data-driven performance measurement systems (KPIs, dashboards, scorecards) to track  operational quality metrics. </p><p>• Conduct root cause analysis (RCA) on systemic failures and implement sustainable corrective measures. • Facilitate cross-functional problem-solving workshops and kaizen events to drive bottom-up process  innovation. </p><p>Education, Skills & Experience Requirements </p><p>• B.Tech (Engineering) from a recognized institution, Post-graduation in Quality Management, Operations,  or Business Excellence is preferred. </p><p>• 15–20 years of progressive experience in Quality Assurance and Process Excellence, with a mandatory background in the Manufacturing sector. </p><p>• Proven track record of leading quality transformations at an organizational level — not limited to departmental or project scope. </p><p>• Hands-on expertise in quality methodologies: Lean, Six Sigma (Black Belt preferred), TQM, Kaizen,  FMEA, and SPC. </p><p>• Deep understanding of quality standards and compliance frameworks (ISO 9001, ISO 14001, TS 16949, or  equivalent). </p><p>• Strong experience in internal and external audit management, CAPA frameworks, and regulatory  compliance. </p><p>• Demonstrated ability to lead cross-functional teams and influence stakeholders across hierarchies. • Experience in digitizing quality processes and working with ERP/QMS tools is desirable. • Excellent analytical, problem-solving, and communication skills with the ability to present to senior  leadership and board-level audiences. </p><p>• Alignment with Company core values of Integrity, Excellence, Responsibility, Pioneering, and Unity</p><h3>experience</h3>20

Role Summary:<br />Work both as individual contributor and in collaboration with team to facilitate & support regulatory requirements, quality systems, and best practices in drug product development Main Accountabilities: ➢ Review of quality control activities at analytical development lab and subcontracted<br />facilities.<br />➢ Compliance in Analytical lab and maintain as per Global requirement.<br />➢ Tracking and maintaining the documents in Analytical as per Regulatory requirement.<br />➢ Participation in the local Manufacturing Review Board (MRB), provide quality input on IMP and manufacturing processes during development. <h3>experience</h3>5