**Summary:** Reality Labs is seeking a medical devices quality management engineer to support the establishment and ongoing operations of a quality management system (QMS) compliant with 21 CFR, EU MDR, and ISO 13485 for the organization. This role will work cross functionally in an organization that is primarily consumer electronics focused but has a growing medical device portfolio to champion the adoption of processes. You will work as part of the Regulatory Affairs and Quality Systems team executing quality system engineering activities for electromechanical devices and/or in software as a medical device (SaMD). **Required Skills:** Medical Devices, Quality Management Systems Engineer Responsibilities: 1. Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. 2. Proactively investigates, identifies, and implements effective Quality Engineering practices. 3. Promotes quality assurance, process controls, and Corrective Action/Preventive Action (CAPA) systems designed to meet or exceed internal and external requirements. 4. Leverage operational experience to meet quality and regulatory goals, define quality management system processes for a medical device product area residing within a larger consumer electronics division. 5. Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices. 6. Support continuous improvement activities, Complaints, Nonconformance Reports, and CAPAs using problem solving methodologies 7. Ishikawa diagram or Fishbone diagram, Pareto, Failure Mode and Effects Analysis. **Minimum Qualifications:** Minimum Qualifications: 8. Currently has, or is in the process of obtaining a Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience. Degree must be completed prior to joining Meta. 9. 3+ years of experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development) 10. Demonstrated knowledge and experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, Medical Device Directive & European Union Medical Device Regulation 11. Demonstrated track record of crafting clear and concise, emails, reports & documents for a broad range of stakeholders. Experience presenting clearly and persuasively to technical and non-technical audience. **Preferred Qualifications:** Preferred Qualifications: 12. Experience with electronic Quality Management System tools for state of the art documentation and record keeping practices 13. Prior experience establishing a new Quality Management System at a large, complex organization. 14. Regulatory Affairs Certification or Certified Quality Engineer/Certified Quality Manager certification 15. Experience with electromechanical devices as well as Software as a Medical Device product development. 16. Experience and personal interactions with Food and Drug Administration and other regulatory agencies through audits and product submissions **Public Compensation:** $102,000/year to $164,000/year + bonus + equity + benefits **Industry:** Internet **Equal Opportunity:** Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment. Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at accommodations-ext@fb.com.