Medical Devices, Quality Management Systems Engineer
Sunnyvale, CA • Burlingame, CA • Full Time
Facebook
Facebook Reality Labs
G and A
Operations
Reality Labs is seeking an experienced medical devices quality management professional to own 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 act as the directly responsible individual for the QMS, be an internal consultant to other functions adopting new standard operating procedures, and share their domain experience in electromechanical devices and/or in software as a medical device (SaMD) in product core teams.
Medical Devices, Quality Management Systems Engineer Responsibilities
- 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.
- Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products.
- Train and coach cross-functional peers on maintaining compliance to internal and external medical device quality system requirements and regulations.
- Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices.
- Lead continuous improvement activities, Non-Conformance Reports, Corrective and Preventive Action and lean initiatives from a quality perspective.
- Utilizes problem solving methodologies
- (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, Failure Mode and Effects Analysis).
- Defines and monitors Key Process Indicators for the quality management system. Prepares dashboards and communications to Top Management on the health of the QMS.
Minimum Qualifications
- Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience.
- 8+ years of work 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 medical device requirements clearly and persuasively to technical and non-technical audience
Preferred Qualifications
- Experience with implementations of electronic Quality Management System tools for state of the art documentation and record keeping practices
- 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.
$170,000/year to $240,000/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
Meta is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice here.
Meta is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, fill out the Accommodations request form.
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Equal Employment Opportunity
Meta is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice here.
Meta is committed to providing reasonable support (called accommodations) in our recruiting processes for candidates with disabilities, long term conditions, mental health conditions or sincerely held religious beliefs, or who are neurodivergent or require pregnancy-related support. If you need assistance or an accommodation due to a disability, fill out the Accommodations request form .