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. We leverage AI to empower physicians, enabling them to make well-informed decisions and significantly improve the lives of their patients. 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. Check out our website for more information at https://www.Cosmohealthconfidence.Com/.Role DescriptionThe 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.ResponsibilitiesQuality Management System Implementation & MaintenanceDesign, 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) requirementsMonitor and interpret new and emerging global quality and regulatory standards, regulations, and guidance documentsAssess impact of regulatory changes on the QMS and implement necessary updates to maintain complianceDevelop and maintain quality manuals, procedures, work instructions, and quality system documentationEstablish and oversee quality metrics and KPIs to measure QMS effectiveness and drive continuous improvementCarry 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 performanceChampion a culture of quality throughout the organization through training, communication, and leadershipInternal Audit ProgramsDesign and lead comprehensive internal audit programs covering all QMS processes and requirementsDevelop risk-based audit schedules ensuring adequate coverage of all regulatory requirementsManage execution of internal audits by providing training, guidance, and performance feedback to audit team.Prepare detailed audit reports with objective evidence, findings, and improvement recommendationsTrack audit findings to closure and verify effectiveness of corrective actionsMaintain audit records and documentation in compliance with regulatory requirementsExternal Audit ManagementServe 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 inspectionsCoordinate audit logistics, documentation reviews, and cross-functional audit response teamsManage audit conduct, ensuring professional and compliant interactions with auditors and inspectorsLead the resolution of audit findings, observations, and non-conformances within required timeframesPrepare and submit responses to certification bodies and regulatory agenciesMaintain ongoing communication with external bodies regarding compliance status and corrective actionsEnsure successful audit outcomes and maintenance of certifications and regulatory clearancesNon-Conformance, CAPA & Complaint ManagementEstablish and manage robust processes for non-conformance identification, documentation, and resolutionOversee the Corrective and Preventive Action (CAPA) system ensuring timely investigation and effective corrective actionsEnsure 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 requirementsEnsure appropriate evaluation of complaints for reportability to relevant regulatory authoritiesMonitor CAPA effectiveness and ensure corrective actions eliminate recurrenceGenerate trending reports and analyses to identify systemic quality issues and provide data input into Post-Market Surveillance, PSURs, Risk Management Files as requested.Interface with cross-functional teams to implement corrective actions across the organizationGood Manufacturing Practices & Good Documentation PracticesEstablish and enforce Good Manufacturing Practices (GMP) across all MedTech AI functions & divisionsImplement and maintain Good Documentation Practices (GDP) including data integrity principlesEnsure compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)Conduct regular assessments of manufacturing and documentation practicesProvide training and guidance on GMP and GDP requirements to all personnelDevelop and implement data integrity policies and controls for both paper and electronic systemsMonitor adherence to documentation standards and investigate deviationsDocument Control & Records ManagementOwn and manage the document control system ensuring proper creation, review, approval, distribution, and archival of controlled documentsEstablish document naming conventions, revision control, and version management processesEnsure appropriate document retention periods are defined and maintained per regulatory requirementsManage records throughout their lifecycle from creation through archival or destructionLead 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 signaturesTrain personnel on document management processes and EDMS functionalityEnsure business continuity during the paper-to-electronic transitionTraining & Competency ManagementDevelop quality and compliance training programs for all personnelEnsure personnel receive appropriate training on QMS requirements, Good Manufacturing Practices, Good Documentation Practices, Information Security and relevant regulationsMaintain training records and competency assessmentsProvide specialized training on audit processes, CAPA, and complaint handlingPhysical Requirements:Expected travel is 30%Equal Opportunity Statement:We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006