Medical Devices, Quality Management Systems Engineer

Requirements

• 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.
• 3+ years of experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development)
• 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
• 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.
• Experience with electronic Quality Management System tools for state of the art documentation and record keeping practices
• Prior experience establishing a new Quality Management System at a large, complex organization.
• Experience with electromechanical devices as well as Software as a Medical Device product development.
• Experience and personal interactions with Food and Drug Administration and other regulatory agencies through audits and product submissions
• About Meta:
• 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.
• $102,000/year to $164,000/year + bonus + equity + benefits
• Individual compensation is determined by skills, qualifications, experience, and location. Compensation details listed in this posting reflect the base hourly rate, monthly rate, or annual salary only, and do not

Additional Information

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). Medical Devices, Quality Management Systems Engineer Responsibilities: 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. Proactively investigates, identifies, and implements effective Quality Engineering practices. Promotes quality assurance, process controls, and Corrective Action/Preventive Action (CAPA) systems designed to meet or exceed internal and external requirements. 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. Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices. Support continuous improvement activities, Complaints, Nonconformance Reports, and CAPAs using problem solving methodologies Ishikawa diagram or Fishbone diagram, Pareto, Failure Mode and Effects Analysis.

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