**Summary:** Reality Labs is seeking experienced medical devices quality management professionals to drive the establishment and ongoing operations of a quality management system (QMS) compliant with 21 CFR, EU MDR, and ISO 13485 for the organization. You will work cross functionally in an organization that is primarily consumer electronics focused but has a growing medical device portfolio of hardware and software products. You will be both an internal consultant to other functions adopting new SOPs and act as an owner of key QMS and Design Control initiatives. **Required Skills:** Medical Devices Quality Systems Engineer, SaMD Responsibilities: 1. Collaborate with systems and software engineering and other product development teams in establishing or revising standard operating procedures for the definition of design history file and device master record deliverables. 2. Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development and manufacturing of medical devices. 3. Collaborate with engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and other design control deliverables. 4. Lead the creation of software risk management deliverables utilizing an International Organization for Standardization 14971 framework plus device master record and design history file elements to meet Food and Drug Administration and ISO requirements. 5. Guide medical device development teams in their execution strategy to Design and Risk Standard Operating Procedures, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports). **Minimum Qualifications:** Minimum Qualifications: 6. Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience. 7. 5+ years experience in Quality Systems Engineering or similar role 8. Experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development) 9. Demonstrated knowledge and experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, European Union Medical Device Regulation 10. 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: 11. Regulatory Affairs Certification or Certified Quality Engineer/Certified Quality Manager certification 12. Certified Quality Auditor 13485: Lead Auditor Certification 13. Experience with electromechanical devices as well as Software as a Medical Device product development. 14. Working knowledge of medical devices with embedded firmware and systems with mobile and cloud applications 15. Experience with Software as a Medical Device and Computer System Assurance best practices. 16. Ideal candidates can execute under your own initiative, seeking feedback and input where appropriate on several projects as a part of our Regulatory Affairs and Quality Systems for Medical Devices squad **Public Compensation:** $139,000/year to $200,000/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.