• Quality Systems Manager

    About Gregor Diagnostics

    Gregor Diagnostics Inc. is a Madison, WI based, venture-backed, molecular diagnostics company developing a groundbreaking screening test for prostate cancer. Gregor’s test will be the first of its kind to not only detect prostate cancer at the earliest stages but also differentiate between indolent and aggressive cancer.

     

    Summary of Role

    The Quality System Manager will design, develop, and implement a Quality System for the development, regulatory approval, and launch of molecular diagnostic test for prostate cancer. This hands-on technical role provides an opportunity to build a quality department from the ground up in a growing molecular diagnostics company. The Quality System Manager will report to the Director of Clinical of Gregor Diagnostics. The ideal candidate has deep expertise in quality organizations for in vitro diagnostics, molecular diagnostics and/or combination medical devices. This position can be in person at Gregor located in Madison, WI or fully remote.

     

    Essential Duties and Responsibilities

    1. Design, develop, and implement a Quality System.
    2. Develop, implement, and maintain a Design Control process.
    3. Develop, implement, and maintain a Document Control process.
    4. Implement and maintain a Design History File on all products in development.
    5. Collaborate across all departments in the organization to maintain quality.
    6. Assist with drafting and compilation of product documentation for regulatory submissions.
    7. Other duties as relates to the overall quality strategy of Gregor Diagnostics.

    Qualifications

    Mandatory Qualifications: Quality System Manager

    Education and industry experience:

    • Bachelor’s degree life sciences or related field
    • Master’s degree in a related field preferred.
    • Minimum of 10 years work experience in quality at a manufacturer of molecular diagnostics or related field.
    • Experience in a supervisory position in a Quality role.

    Deep working knowledge of:

    • Regulations around quality systems including FDA 21 CFR 820, ISO 13485, and ISO 9001.
    • Risk Management process compliant to ISO 14971
    • Design and Process validation activities
    • Good Manufacturing Process (GMP)
    • Strong organizational and time management skills.
    • Strong verbal and written communication skills.
    • Strong analytical, problem solving and decision-making skills.
    • Computer skills including experience with project planning, data management and records retention applications.
    • Ability to work in a team environment and adapt to changing plans and circumstances.
    • Ability to prioritize, organize and delegate assignments.

    Preferred Qualifications

    Experience serving as the Quality subject matter expert for:

    • Regulatory submissions for new product clearance by FDA
    • Audits (internal, FDA, and/or by EU notified bodies)
    • Experience gaining ISO 13485 certification for a new medical device manufacturer
    • Experience with post market surveillance

    Physical Requirements

    • Ability to work for up to 8 hours a day in an office environment.
    • Ability to lift and move up to 40 pounds on an occasional basis.

    Benefits

    Gregor Diagnostics offers a comprehensive and competitive benefits package including:

    • Competitive salary
    • Stock options
    • Full health, dental, and vision insurance for employees.
    • 50% insurance coverage for dependents
    • 401k match
    • Flexible paid time off and work schedule

    Please submit to: careers@gregordiagnostics.com

     

    Gregor Diagnostics is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.

     

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