At Cosmo, we are at the forefront of revolutionizing healthcare through our groundbreaking technology. With our innovative advancements in live endoscopy, we are transforming the landscape of medical diagnostics. Our dedication to excellence has resulted in creating GI Genius: our AI-enabled medical device for live endoscopy has received FDA approval and is successfully deployed in hospitals worldwide, making a significant impact in the field of healthcare. The Quality Assurance Manager – R&D is responsible for establishing, implementing, and maintaining a robust Quality Management System (QMS) that meets the requirements of ISO 13485, ISO 27001, ISO 42001, MDSAP, and US Quality Management System Regulation and applicable global regulatory requirements. The Quality Assurance Manager – R&D shall also be the Management Representative for the company. This position serves as the guardian of quality and compliance across the company, ensuring our medical device products—both hardware and SaMD—are developed, manufactured, and distributed in accordance with global regulatory standards. This position also serves as the primary interface with external certification bodies, notified bodies, and regulatory authorities and will lead the transformation of our quality systems from paper-based processes to a modern electronic document management system while building a culture of quality, compliance, and continuous improvement throughout the organization. Quality Management System Implementation & Maintenance Design, implement, and maintain an integrated Quality Management System that meets the requirements of ISO 13485, ISO 27001, ISO 42001, MDSAP, and United States QMSR as well as all relevant global regulatory requirements. Ensure the QMS effectively addresses both hardware medical device and Software as a Medical Device (SaMD) requirements Monitor and interpret new and emerging global quality and regulatory standards, regulations, and guidance documents Assess impact of regulatory changes on the QMS and implement necessary updates to maintain compliance Develop and maintain quality manuals, procedures, work instructions, and quality system documentation Establish and oversee quality metrics and KPIs to measure QMS effectiveness and drive continuous improvement Carry out the duties of the Management Representative as per ISO 13485, 5.5.2 and 21 CFR 820.20 (3) Lead management review meetings and ensure top management visibility into quality system performance Champion a culture of quality throughout the organization through training, communication, and leadership Develop risk-based audit schedules ensuring adequate coverage of all regulatory requirements Manage execution of internal audits by providing training, guidance, and performance feedback to audit team. Maintain audit records and documentation in compliance with regulatory requirements External Audit Management Serve as the primary point of contact for external certification bodies, notified bodies (EU MDR), and regulatory authorities (FDA, Health Canada, etc.) Lead preparation activities for certification audits, surveillance audits, and regulatory inspections Prepare and submit responses to certification bodies and regulatory agencies Ensure successful audit outcomes and maintenance of certifications and regulatory clearances Non-Conformance, CAPA & Complaint Management Ensure root cause analysis activities are conducted using structured methodologies (5 Why, Fishbone, Fault Tree Analysis) Manage the complaint handling process in accordance with ISO 13485 and FDA QMSR and other applicable regulatory requirements Ensure appropriate evaluation of complaints for reportability to relevant regulatory authorities Monitor CAPA effectiveness and ensure corrective actions eliminate recurrence Generate trending reports and analyses to identify systemic quality issues and provide data input into Post-Market Surveillance, PSURs, Risk Management Files as requested. Implement and maintain Good Documentation Practices (GDP) including data integrity principles Provide training and guidance on GMP and GDP requirements to all personnel Develop and implement data integrity policies and controls for both paper and electronic systems Monitor adherence to documentation standards and investigate deviations Document Control & Records Management Own and manage the document control system ensuring proper creation, review, approval, distribution, and archival of controlled documents Establish document naming conventions, revision control, and version management processes Ensure appropriate document retention periods are defined and maintained per regulatory requirements Manage records throughout their lifecycle from creation through archival or destruction Lead the transition from paper-based QMS to Electronic Document Management System (EDMS) Select, implement, and validate EDMS ensuring 21 CFR Part 11 compliance for electronic records and signatures Train personnel on document management processes and EDMS functionality Training & Competency Management Develop quality and compliance training programs for all personnel Ensure personnel receive appropriate training on QMS requirements, Good Manufacturing Practices, Good Documentation Practices, Information Security and relevant regulations Maintain training records and competency assessments Provide specialized training on audit processes, CAPA, and complaint handling Expected travel is 30% We support equal opportunities, without any discrimination;