• Quality Systems Manager/Director

    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 and/or molecular diagnostics. This position is located at Gregor in Madison, WI.

    Essential Duties and Responsibilities

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

    Qualifications

    • Education and industry experience:
      • Bachelor’s degree life sciences or related field with 5-10 years’ experience in a Quality Assurance position in the IVD, Medical Devices or Biotech industries
      • Expert knowledge of FDA QSR, ISO13485, and ISO 14971 with emphasis on product development
      • Preference given to candidates with demonstrable experience in a startup/small company
      • Strong preference for experience with IVD design and development
      • Experience in a supervisory position in Quality Affairs
      • Experience with quality requirements for PMA submission highly desired
      • Ability to train inter-disciplinary teams in quality processes, procedures, and adherence
      • Demonstrated experience working with cross-functional groups (R&D, Eng., Clin, Reg, etc.) requiring strong inter-personal skills, excellent communication skills, and the ability to work well under pressure
      • Experience gaining ISO 13485 certification as a new medical device manufacturer
      • Experience serving as the Quality subject matter expert for:
        • Regulatory submissions for new product clearance, PMA by FDA
        • Audits (internal, FDA, and/or by EU notified bodies)
    • Computer skills including experience with project planning, data management and records retention applications.
    • Must be located near Madison, WI or willing to relocate

    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
    • Attractive stock options
    • Health, dental, and vision insurance for employees and family
    • 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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