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
Role Description
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.
Responsibilities
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
Internal Audit Programs
* Design and lead comprehensive internal audit programs covering all QMS processes and requirements
* 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.
* Prepare detailed audit reports with objective evidence, findings, and improvement recommendations
* Track audit findings to closure and verify effectiveness of corrective actions
* 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
* Coordinate audit logistics, documentation reviews, and cross-functional audit response teams
* Manage audit conduct, ensuring professional and compliant interactions with auditors and inspectors
* Lead the resolution of audit findings, observations, and non-conformances within required timeframes
* Prepare and submit responses to certification bodies and regulatory agencies
* Maintain ongoing communication with external bodies regarding compliance status and corrective actions
* Ensure successful audit outcomes and maintenance of certifications and regulatory clearances
Non-Conformance, CAPA & Complaint Management
* Establish and manage robust processes for non-conformance identification, documentation, and resolution
* Oversee the Corrective and Preventive Action (CAPA) system ensuring timely investigation and effective corrective actions
* 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.
* Interface with cross-functional teams to implement corrective actions across the organization
Good Manufacturing Practices & Good Documentation Practices
* Establish and enforce Good Manufacturing Practices (GMP) across all MedTech AI functions & divisions
* Implement and maintain Good Documentation Practices (GDP) including data integrity principles
* Ensure compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)
* Conduct regular assessments of manufacturing and documentation practices
* 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
* Ensure business continuity during the paper-to-electronic transition
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
Physical Requirements:
Expected travel is 30%
Equal Opportunity Statement:
We support equal opportunities, without any discrimination; The research complies with Legislative Decree 198/2006