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Conshohocken

    Quality Assurance Manager - Conshohocken, United States - Extremity Care

    Extremity Care
    Extremity Care Conshohocken, United States

    4 weeks ago

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    Description
    Job Description

    Job Description Salary:
    $80, $85,000.00 per year

    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, other regulations (as appropriate), and industry standards.
    • Author, revise, and maintain
    procedures/controlled

    documents according to FDA, AATB, and other applicable regulations.

    • Manage deviations, nonconformances, complaints, CAPAs, SCARs, and safety incidents and ensure timely completion of associated investigations.
    • Ensure adequacy of investigations with respect to root cause analysis and CAPA assessment (as appropriate).
    • Establish, evaluate, report, and provide improvements (where appropriate) for quality metrics.
    • 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 quality.
    • Support implementation of new projects/product development.
    • Support development of
    validation/qualification

    protocols and summary reports in accordance with regulatory requirements and industry best practices.

    • Review and approve
    validation/verification

    protocols, execution data, and summary reports.

    • 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 vendors.
    • Manage direct reports and monitor individual performance.
    • Maintain records in accordance with standard operating procedures.
    • Attend/participate in offsite business
    meetings/conferences.

    • Perform other related duties as assigned.

    Skills & Abilities:

    • Leadership & Management skills
    • Attention to detail
    • Organized
    • Verbal/Written Communication skills
    • Analytical Thinking skills
    • Technical Writing skills
    • Multi-tasking skills

    Education & Experience:

    • Bachelor's degree in a biological science or related field required.
    • 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

    #J-18808-Ljbffr
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