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San Francisco Bay Area, CA

  • Senior Quality Engineer

    Fremont, CA

    POSITION SUMMARY Ensures QMS processes are being followed according to established procedures. Participates as a team member in the product development process from concept through the life of the project and ensures project teams are utilizing the company’s quality systems and appropriate regulatory requirements and standards throughout the project.

    ESSENTIAL DUTIES AND RESPONSIBILITIES

    • Lead preparation efforts for internal and external audits
    • Provide guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
    • Designs and implements product and process documentation, including inspection plans
    • Conducts feasibility studies of the design to determine ability to function as intended
    • Investigates and evaluates material biocompatibility and appropriate methods of sterilization if applicable.
    • Maintains detailed documentation throughout all phases of research and development, design verification and validation, design transfer, and production on assigned projects.
    • Conduct risk analysis for products and processes under development
    • Interface with customers to generate quality plans and supplier quality agreements.
    • Ensures outside supplier quality systems meet company’s requirements and coordinates any activities with the supplier as needed.
    • Develops verification and validation test protocols
    • Develops product submission documentation if required by the customer
    • Participates in design reviews to ensure the design control deliverables for each phase are met
    • Report quality system metrics to top management as required
    • Supports various manufacturing activities and participates in the development, qualification of product/equipment and process.
    • Investigates and resolves issues with out of tolerance equipment
    • Recommends changes to improve product quality and performance
    • Meet assigned minimum weekly billable target
    • Any other duties as assigned.

    REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE

    • Bachelor’s degree in Engineering is desired
    • Minimum 5 years of medical device product design and development experience is required
    • Demonstrated ability to bring products from concept to market
    • Ability to interact with client companies in a professional manner
    • Familiarity with FDA, QSR, and ISO 13485 medical device regulations and standards
    • Familiarity with Minitab or equivalent data analysis package
    • Working knowledge of probability and statistics
    • Depth of knowledge in one or more clinical areas, product areas, and technical areas.
    • Flexibility, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit

    WORKING CONDITIONS / PHYSICAL DEMANDS

    • Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery, and tools.
    • May lift up to 30 pounds and stand for extended periods of time.
    • Must tolerate exposure to chemicals found in the company’s environment.


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