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San Francisco Bay Area, CA

  • Senior Quality Engineer (Design Assurance R&D support)

    Position Overview

    The Sr. Quality Engineer (Design Assurance) works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with the company policies and procedures. Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other applicable regulations. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible.

    Essential Job Functions

    • Actively participate in Design Control activities such as:
      • Ensure new Design projects and Design Change activities are performed in compliance to Design Control procedure.
      • Design reviews to document and ensure that the design meets the intended customer requirements.
      • Draft Design Verification and Validation Test Protocols, Methods and Reports.
      • Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.
      • Responsible for ongoing management of Risk Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA.), Risk Management Plans and Reports.
      • Perform Design Verification and Validation Testing.
      • Lead/Coordinate/perform verification/ validation activities for:
        • Biocompatibility Testing
        • Packaging Validation
        • Accelerated and Real Time Shelf-Life/Aging Studies
        • Sterilization Validation
        • Test Method Validation
    • Provide support to Manufacturing and Operations:
    • Evaluate/investigate and document investigation results for returned devices from clinical studies and commercial complaints.
    • Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.)
    • Analyze and review data for key Quality metrics to identify any significant trends.
    • Initiate, review, and approve Document Change Orders (DCO.)
    • Drive Standard Gap Assessment activities.
    • Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)
    • Support ongoing Regulatory submission activities and product approval processes.
    • Participate in the implementation and continuous improvement of the Quality Management System.
    • Provide technical support to the Quality inspection group.
    • Identify testing and analysis required for the finished device to ensure conformance to product specifications.
    • Develop device Quality Plans to ensure that the elements of the Quality Management System are appropriately described and managed.
    • Audit DHFs to ensure compliance to Design Control procedure.
    • Perform or assist in root cause analysis of product non-conformances found in manufacturing.
    • Assist in qualifying molds, fixtures, tooling, and equipment.
    • Perform/support process validations.
    • Identify, drive, and implement process improvements.
    • Participate in Supplier Quality activities including material non-conformances and Supplier audits.
    • Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.
    • Recommend QC sampling plans based on desired confidence and reliability limits.

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