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    Quality Assurance Manager - San Antonio, United States - Extremity Care

    Extremity Care
    Extremity Care San Antonio, United States

    2 weeks ago

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    Description

    Job Description

    Job DescriptionSalary: From $70, 800.

    Purpose:

    The Quality Assurance Manager is responsible for ensuring that all products and services meet established quality standards.

    Duties & Responsibilities:

    • Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, cGMP/CGTP, and other organizations policies and procedures.
    • Author, revise, and maintain procedures/controlled documents according to FDA, AATB, and other applicable regulations.
    • Manage processes and efficiency in department to support organizational strategic objectives.
    • Establish, evaluate, report, and provide improvements (where appropriate) for quality
    • Manage and oversee review of HCT/P donor records for final product release in accordance with standard operating procedures and regulatory/accrediting agency requirements.
    • Manage and oversee review of quality control records to include equipment cleaning, maintenance, environmental monitoring, and supply inspections.
    • Assist with training of processes and corrective actions relating to
    • Support development of validation/qualification protocols and summary reports in accordance with regulatory requirements and industry best practices.
    • Review and approve qualification/ validation/verification protocols, execution data, and summary
    • Support internal, client, and regulatory agency audits to ensure compliance with regulatory requirements, certification requirements, and internal policies and procedures.
    • Maintain professional working relationships with customers, partners, and
    • Manage direct reports and monitor individual
    • Maintain records in accordance with standard operating
    • Attend/participate in offsite business meetings/conferences.
    • Starting your job duties on time, staying on the job throughout the assigned shift to complete duties properly, and attending all scheduled meetings and appointments
    • Perform other related duties as

    Skills & Abilities:

    • Leadership & Management skills
    • Attention to detail
    • Organized
    • Verbal/Written Communication skills
    • Analytical Thinking skills
    • Technical Writing skills
    • Multi-tasking skills
    • Ability to secure and maintain a favorable background investigation and clearance

    Education & Experience:

    • Bachelor's degree in a biological science or related field
    • At least 5 years of experience in quality in an FDA regulated environment for HCT/Ps and/or medical devices (or related field), with progressive management responsibility/experience
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