QA / QC Manager

About the Role: We are establishing a new manufacturing unit for medical devices and IVD reagents at YEIDA. As we prepare for licensing and full-scale production, we are hiring a Senior QA/QC & Regulatory Affairs Manager to lead all quality and regulatory activities from day one. This is a critical leadership position responsible for setting up the QMS, ensuring ISO 13485 and MDR 2017 compliance, overseeing product quality, and ensuring audit and licensing readiness. Key Responsibilities: Quality Assurance (QA): Establish and maintain the Quality Management System (QMS) as per ISO 13485 and MDR 2017. Draft, review, and approve SOPs, Quality Manual, DHR, DMR, and related documentation. Oversee implementation of GMP, risk management, and CAPA systems. Lead internal audits, management reviews, and maintain audit preparedness at all times. Ensure compliance with CDSCO, IVD guidelines, and other applicable standards. Quality Control (QC): Supervise raw material, in-process, and final product testing for IVD reagents. Approve test methods, analytical procedures, and equipment qualification protocols. Review batch records, approve Certificate of Analysis (CoA), and stability data. Ensure proper lab setup, calibration of instruments, and environmental monitoring. Regulatory Affairs :Prepare and file regulatory submissions for manufacturing site licensing, product registration, and other statutory filings. Maintain regulatory dossiers as per MDR 2017 and applicable international standards. Serve as the point of contact during inspections and regulatory audits (CDSCO, ISO, etc.). Monitor regulatory updates and implement necessary changes in QMS or product documentation. Team & Facility Oversight: Build and mentor the QA/QC and documentation team. Collaborate with production and R&D to ensure product quality and compliance. Participate in facility planning to ensure compliance with regulatory and quality standards. Key Requirements:7–12 years of experience in QA/QC and Regulatory Affairs in medical device or IVD reagent manufacturing. Strong command over ISO 13485, MDR 2017, CDSCO norms, and GMP compliance. Experience in handling regulatory audits, technical files, and licensing procedures. Sound knowledge of lab practices, contamination control, and analytical techniques. Strong leadership, documentation, and cross-functional coordination skills. Qualifications: M.Sc. / B.Tech / M.Tech in Biotechnology, Biochemistry, Chemistry, or Life Sciences. Certification in ISO 13485 Lead Auditor, Regulatory Affairs, or GMP preferred. What We Offer: A core leadership role in a greenfield manufacturing setup. Ownership of end-to-end quality and regulatory processes. Exposure to international markets and audit frameworks. Long-term career growth in a high-impact, compliant manufacturing environment.