• Medical Devices, Quality Management Systems…

    Meta (Burlingame, CA)


    Summary:

    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.

    Required Skills:

    Medical Devices, Quality Management Systems Engineer Responsibilities:

    1. 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.

    2. Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for electromechanical and SaMD products.

    3. Train and coach cross-functional peers on maintaining compliance to internal and external medical device quality system requirements and regulations.

    4. Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices.

    5. Lead continuous improvement activities, Non-Conformance Reports, Corrective and Preventive Action and lean initiatives from a quality perspective.

    6. Utilizes problem solving methodologies

    7. (CAPA, Is/Is not diagram/Fishbone diagram, Pareto, Failure Mode and Effects Analysis).

    8. 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:

    Minimum Qualifications:

    9. Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience.

    10. 8+ years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, Pharma, LifeSciences, Quality and/or Development)

    11. 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

    12. Demonstrated track record of crafting clear and concise, emails, reports & documents for a broad range of stakeholders.

    13. Experience presenting medical device requirements clearly and persuasively to technical and non-technical audience

    Preferred Qualifications:

    Preferred Qualifications:

    14. Experience with implementations of electronic Quality Management System tools for state of the art documentation and record keeping practices

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

    16. Experience with electromechanical devices as well as Software as a Medical Device product development.

    17. Experience and personal interactions with Food and Drug Administration and other regulatory agencies through audits and product submissions

    Public Compensation:

    $170,000/year to $240,000/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 [email protected].