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    Manager of Quality Improvement - San Diego, United States - Modular Medical Inc

    Modular Medical Inc
    Modular Medical Inc San Diego, United States

    4 weeks ago

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    Description

    Job Description

    Job DescriptionJob Description

    Essential Job Functions:

    Position responsibilities include, but may not be limited to the following:

    • Develop and implement comprehensive quality assurance strategies, policies, and procedures that ensure compliance with applicable regulations and standards in the medical device industry
    • Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and operations, to identify and address quality-related issues and drive continuous improvement
    • Responsible for quality system improvements for the company to gain certification to the ISO 13485 European standards along with compliance to MDR 2017/745/EU.
    • Manage and run a weekly ECO meeting to ensure changes are progressing through the quality system in a compliant and timely manner
    • Develop quality metrics and monitoring to present on an ongoing basis and feed into Management Reviews
    • Act as a quality representative and liaison with the contract manufacturing to ensure compliance with regulations.
    • Closely monitors established leading indicators, measures daily/weekly outputs and plans activities to course-correct as needed to ensure overall timeliness metrics are sustained.
    • Develop and manage the overall post market surveillance (PMS) activities to ensure compliance with FDA MDR and other evolving regulatory requirements.
    • Identify and communicate emerging trends in post market surveillance to drive product improvements.
    • Generate/update PMS system procedures as required (e.g., SQP, SOP, protocols, and reports).
    • Develop and maintain up-to-date knowledge on regulatory compliance, specifically FDA and EU requirements.
    • Work closely with other departments to set up quality files suitable for regulatory submissions
    • All other duties as assigned

    Requirements

    Education:

    Bachelors degree in engineering, science, or a related field.

    Experience:

    • Minimum of 10 years of experience in quality assurance in the medical device industry
    • Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards
    • In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulations and standards
    • Experience leading product development teams and ensuring that products meet or exceed quality standards and customer expectations

    Skills (Required):

    • Ability to handle multiple tasks while ensuring timely and accurate completion
    • Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans
    • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies

    Physical:

    • Ability to sit or stand for extended periods of time
    • Ability to lift and/or move up to 35 pounds
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