XLO

Company Description XLO is India's widest manufacturer of joint replacement implants, trauma products, and bone cement, serving both overseas and domestic markets since 1992. Renowned for quality, reliability, consistency, and service in the orthopaedic and traumatology sectors, XLO operates a full-fledged manufacturing and quality assurance facility in New Delhi, India. Our products, crafted from Titanium AI6V4(ELI) and Stainless Steel 316L per ASTM Standards, are designed to improve mobility and significantly enhance the quality of life. We provide versatile implants that are easy to use and offer exceptional value. Role Description This is a full-time on-site role located in Delhi, India, for a QA/RA Manager. The QA/RA Manager will be responsible for overseeing quality assurance and regulatory affairs activities, conducting quality audits, implementing and maintaining Good Manufacturing Practices (GMP), and ensuring consistent quality management across the production process. Daily tasks include supervising quality control processes, developing and enforcing quality standards, and ensuring compliance with regulatory requirements. Job Title: QA/RA Manager Location - Okhla Phase -1 Delhi. Salary - Best in Industry. Key Responsibilities: Regulatory Affairs (RA): • Ensure compliance with applicable global regulations: Indian MDR, ISO 13485, EU MDR (2017/745), USFDA 21 CFR 820, and MDSAP. • Prepare and maintain regulatory submissions (Technical Files, 510(k), STED, etc.) for CE Marking, USFDA clearance, and Indian CDSCO licensing. • Serve as the primary contact for regulatory authorities and Notified Bodies. • Monitor and interpret changes in regulations; ensure timely implementation within QMS and product lifecycle. • Manage product registrations, renewals, and labeling compliance in domestic and international markets. • Support clinical evaluation reports (CER), risk management (ISO 14971), and post-market surveillance. Quality Assurance (QA): • Develop, implement, and maintain a robust Quality Management System (QMS) in compliance with ISO 13485. • Lead internal audits, external audits, and regulatory inspections (CDSCO, NB, USFDA). • Drive CAPA and non-conformance (NC) management: lead root cause analysis, define corrective/preventive actions, and monitor effectiveness. • Oversee Change Control, design reviews, and process validations. • Manage Document Control for DHFs, DMRs, SOPs, risk files, batch records, and validation protocols. • Approve and release product batches post review of sterilization, biocompatibility, and inspection data. • Supervise vendor quality audits, material reviews, and supplier scorecards. • Ensure effective training programs on GMP, QMS, and regulatory requirements across all departments. Product & Process Oversight: • Lead design assurance activities, including risk analysis (ISO 14971), design verification/validation, and usability studies. • Oversee sterilization validation (ISO 11135 for EO) and ongoing routine controls. • Supervise cleanroom environmental monitoring and contamination control measures. • Coordinate with cross-functional teams (R&D, Manufacturing, QC, RA) to ensure compliance throughout the product lifecycle. Interested candidates can share their updated CV on HR1@XLO.IN or WhatsApp - 7290005414 #QA /RA Manager #Immediate requirement #QA Manager #RA Manager #Manufacturing #Healthcare #Orthiopaedics # Implants.