Meta
Medical Devices, Quality Management Systems Engineer
Meta - Burlingame, California, United States, 94012
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Overview
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Overview
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).
Responsibilities
Identifies and implements effective process control systems to support the development, qualification, and ongoing 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 such as Ishikawa diagram or Fishbone diagram, Pareto, and 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, Life Sciences, 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 audiences. 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. Compensation:
US$102,000/year to US$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. 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. 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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Identifies and implements effective process control systems to support the development, qualification, and ongoing 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 such as Ishikawa diagram or Fishbone diagram, Pareto, and 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, Life Sciences, 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 audiences. 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. Compensation:
US$102,000/year to US$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. 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. 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 .
#J-18808-Ljbffr