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    Director, Quality Operations - Lewisville, United States - Quest Diagnostics

    Quest Diagnostics
    Quest Diagnostics Lewisville, United States

    1 day ago

    Quest Diagnostics background
    Description

    Job Title: Director, Quality Operations at Quest Diagnostics


    The Director of Quality Operations will lead Quality Control & Quality Assurance activities at the site, ensuring compliance with USA FDA regulations for IVD products. They will be tasked with translating the company's quality strategy into SOPs and processes to meet global regulatory standards. The role includes oversight of Raw Material / Component release, Quality & Validation Engineering, and Site Compliance & Inspection Readiness.


    • Oversees day-to-day Quality Operations activities including Raw Material & Component Release and Root Cause Investigation.
    • Collaborates to drive compliance excellence and process efficiency.
    • Drives implementation plan of controlled document management and review of GxP documentation.
    • Manages incoming raw material and warehouse organization for compliance.
    • Works with procurement and R&D teams to ensure inventory levels and product quality.
    • Implements policies to maintain an effective equipment program in collaboration with Biomedical Engineering.
    • Leads strategy development and continuous improvement initiatives for Quality processes.

    Qualifications:

    • 8-10 years experience in Pharmaceutical, Medical Device or Biotech Industry.
    • Experience in project management and continuous improvement methodologies preferred.
    • Working knowledge of FDA regulations, ISO standards, and quality systems.
    • Demonstrated ability to manage compliance issues and risks.
    • Strong relationships with cross-functional teams and ability to host external Quality System inspections.
    • Excellent conflict resolution, communication, and organizational management skills.
    • Bachelor's degree required.

    EEO:

    Quest Diagnostics is committed to equal employment opportunities, recruiting, hiring, and promoting individuals based on qualifications without regard to various factors. The company observes minimum age requirements as per the law.

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