Medical Devices, Quality Management Systems Engineer

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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.
• Regulatory Affairs Certification or Certified Quality Engineer/Certified Quality Manager certification
• 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

For those who live in or expect to work from California if hired for this position, please click here for additional information.

About Meta

Meta builds technologies that help people connect, find communities, and grow businesses. When Facebook launched in 2004, it changed the way people connect. Apps like Messenger, Instagram and WhatsApp further empowered billions around the world. Now, Meta is moving beyond 2D screens toward immersive experiences like augmented and virtual reality to help build the next evolution in social technology. People who choose to build their careers by building with us at Meta help shape a future that will take us beyond what digital connection makes possible today-beyond the constraints of screens, the limits of distance, and even the rules of physics.

$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 include bonus, equity or sales incentives, if applicable. In addition to base compensation, Meta offers benefits. Learn more about benefits at Meta.

Equal Employment Opportunity

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