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    Senior Quality Assurance Manager - San Jose, United States - Connect Life Science

    Connect Life Science
    Connect Life Science San Jose, United States

    1 month ago

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    Description

    Job Title:
    Senior Quality Assurance Manager

    Compensation:
    $150,000 - $200,000, plus Comprehensive Benefits and Stock Options

    Industry:
    Medical Devices


    Location:
    San Jose, CA


    We are seeking a seasoned leader in the field of Medical Devices, equipped with an engineering background and a proactive approach, to spearhead a team of 5 direct reports through the development phase of a new product, working closely with contract manufacturers and driving the implementation of a new eQMS system.


    Responsibilities:
    Offer technical mentorship to Quality Engineers
    Drive the transition from a paper-based system to electronic Document Control and Training modules within our QMS system
    Lead or facilitate regulatory audits and internal audits
    Oversee the supplier audit program
    Liaise with multiple CMOs
    Take charge of the Corrective and Preventive Action Process
    Ensure the Document Control system maintains compliance with regulations and procedures during changes to quality system documents
    Conduct training on quality assurance, internal procedures, and Good Manufacturing Practices
    Draft, execute, and/or authorize changes to controlled documents
    Uphold internal procedures for cGMP production in line with ISO 13485:2016 and FDA QSR
    Supervise QA staff, overseeing quality assurance duties

    Experience:
    Bachelor's degree in a scientific or technical discipline
    Over 10 years of direct quality engineering and quality assurance experience in the medical device sector
    Experience working with contract manufacturers
    Experience implementing eQMS
    Experience in start-up or mid-sized companies is desirable
    Exposure to product transfers and integrations from product acquisitions is advantageous
    Working knowledge of ISO 13485:2016 and FDA QSR regulations

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