Reality Labs is seeking experienced medical devices quality management professionals to drive the establishment and ongoing operations of a quality management system (QMS) compliant with 21 CFR, EU MDR, and ISO 13485 for the organization. You will work cross functionally in an organization that is primarily consumer electronics focused but has a growing medical device portfolio of hardware and software products. You will be both an internal consultant to other functions adopting new SOPs and act as an owner of key QMS and Design Control initiatives.
Medical Devices Quality Systems Engineer, SaMD Responsibilities:
- Collaborate with systems and software engineering and other product development teams in establishing or revising standard operating procedures for the definition of design history file and device master record deliverables.
- Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development and manufacturing of medical devices.
- Collaborate with engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and other design control deliverables.
- Lead the creation of software risk management deliverables utilizing an International Organization for Standardization 14971 framework plus device master record and design history file elements to meet Food and Drug Administration and ISO requirements.
- Guide medical device development teams in their execution strategy to Design and Risk Standard Operating Procedures, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports).
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- Bachelor's degree in Computer Science, Computer Engineering, relevant technical field, or equivalent practical experience.
- 5+ years experience in Quality Systems Engineering or similar role
- 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, 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
- Regulatory Affairs Certification or Certified Quality Engineer/Certified Quality Manager certification
- Certified Quality Auditor 13485: Lead Auditor Certification
- Experience with electromechanical devices as well as Software as a Medical Device product development.
- Working knowledge of medical devices with embedded firmware and systems with mobile and cloud applications
- Experience with Software as a Medical Device and Computer System Assurance best practices.
- Ideal candidates can execute under your own initiative, seeking feedback and input where appropriate on several projects as a part of our Regulatory Affairs and Quality Systems for Medical Devices squad
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$139,000/year to $200,000/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.