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    Sr. Quality Assurance Engineer - Santa Rosa, United States - Endologix

    Endologix
    Endologix Santa Rosa, United States

    4 weeks ago

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    Description
    Overview

    Facilitate compliance to applicable internal and external requirements for the Design Control process. Collaborate with R&D, Regulatory, Clinical, Manufacturing, and other departments to help facilitate the successful execution of the Design Control and Risk Management processes. Accountable for Design Assurance Engineering deliverables required within the Design Control process.

    Responsibilities
    • Responsible for ensuring compliance with all federal, state, local, and company regulations, policies, and procedures.
    • Provide expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques.
    • Lead test method development and validation activities for product enhancement programs.
    • Assist with driving opportunities internally and with existing suppliers, including support for process (IQ/OQ/PQ) development to ensure robust product design and manufacturing.
    • Lead Design Assurance Engineering activities to improve customer satisfaction and successful achievement of corporate and department quality objectives.
    • Support investigations for potential product or process failures encountered during the lifecycle of products.
    • Ensure Design Assurance Engineering support of customer complaint investigations as required.
    • Maintain an up-to-date knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk Management, and Statistical Techniques including company products, policies, and procedures.
    • Lead the development of Risk Management activities and facilitates updates to Risk Management files through regularly scheduled meetings.
    • Identifies hazards, mitigates risks associated with hazards, and updates occurrence ratings in FMEAs.
    Qualifications
    • Excellent verbal and written communication skills
    • Working knowledge of GMP/QSR, ISO, EUMDR, and other applicable regulations is expected.
    • Working knowledge of desktop computer, office software, and e-mail is required. Knowledge of Minitab statistical software is preferred.
    • Ability to handle multiple tasks simultaneously and ability to manage project timelines.
    • Detail oriented. Must be accurate in performing statistical techniques and review of documentation containing highly detailed information/data.
    Education:
    • Bachelor's degree in a scientific discipline or equivalent
    Experience:
    • Minimum of 5 years experience in the Medical Device Industry.
    • Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
    Compensation:

    $82, $130,000.00
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