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    Quality Manager - Dallas, United States - (SWM) Schweitzer-Mauduit International, Inc.

    (SWM) Schweitzer-Mauduit International, Inc.
    (SWM) Schweitzer-Mauduit International, Inc. Dallas, United States

    1 week ago

    Default job background
    Description

    Position Title:
    Quality Manager

    Location:
    Dallas, Texas


    JOB DESCRIPTION:
    We have an exciting opportunity to join our QA Team, as

    Quality Manager

    . In this role, you will be responsible for

    manag

    ing

    and monitor

    ing

    the quality

    activities of manufacturing,

    supplier

    and customer

    operations.

    Your day-to-day leadership role overseeing quality assurance will positively affect Mativ's future growth. You

    will

    oversee QA

    personnel to ensure the attainment of goals set for overall quality assurance, control systems, quality management

    documentation, and overall quality reactive and proactive activities are met for the

    Dallas

    site.

    RESPONSIBILITIES:
    Plans, coordinates, and directs quality assurance

    /

    control

    programs and help establish standards designed to ensure continuous production of products by performing duties.
    Review and evaluate inputs related to the Quality Management System for compliance and trends
    Directly supervise

    the

    Quality Team

    ; m

    anages department and overall expectations pertaining to

    priorities,

    budget

    , cost

    s

    and resources

    ; e

    stablish and maintain policy for documentation of all products

    .
    Audits production facility to ensure compliance with applicable

    international

    stan

    dards

    and regulatory requirements,


    ISO
    13485

    ,


    ISO22716,


    ISO14971,


    QSR
    – 21 CFR 810

    , and GMP's

    – 21 CFR 210/211

    .
    Monitor and advising the performance of the site quality management system, producing data, and measuring quality operations against set standards

    .
    Review products, processes and systems on an ongoing basis to determine where improvements can be made

    ; wo

    rk

    s

    with

    Q

    uality

    ,

    Supply Chain

    and operations

    to establish procedures, standards, and systems

    .
    Work with

    Supply Chain

    and

    external suppliers

    to est

    ablish quality requirements for materials and components

    ; w

    ork

    s

    with

    operations and engineering

    to establish procedures,

    specifications,

    standards, and systems

    .
    Manage the selection and development of people, resources, and budgets necessary to perform the functions of the department

    ; t

    rains workforce as required in various quality me

    thods, standards and procedures

    .
    Ensure

    s

    Quality system effectiveness and co

    nformance to industry standards

    and applicable internatio

    nal and regulatory requirements;

    Report

    s

    to management on the effectiveness of the quality system.

    QUALIFICATIONS:
    Must have a Bachelor's degree (B.A/B.S.) in a technical field; chemistry preferred.

    Minimum of 10 to 12 years applicable/related experience in a decision making role for the Medical Device Industry, OTC Drug and Cosmetic product.

    Preference some experience with liquid fill products – lotions, creams, gels, powders

    in

    Liquid Manufacturing site

    s

    .
    Must be able to present projects, findings, to a large group and interface with the group.
    Must have strong experience with writing procedures and standards; experience in Quality Assurance and Quality Control.
    Excellent problem solving, analytical skills and risk & crisis management.
    Must have excellent communications skills with internal and external customers.
    Knowledge of Validation (IQ, OQ, PQ) for Cleaning, Class 1/Class II Medical Devices, OTC Drug and Cosmetic products.
    Experience managing a large staff

    .
    Must have experience and knowledge of
    ISO13485,
    ISO14971 and 22716, 21CFR 820, 210/211 and

    cGMP;

    Sterilization; lab testing – physical, analytical and micro.
    New Product Development (Formulation Technology Transfer) and Design Control
    Hosting FDA,
    ISOand Customer Audits; Water Systems, Environmental Monitoring, Stability programs; MAV, AQL, and Annual Product Reviews.
    Self- motivated professional, driven individual with a strategic mindset.
    Preferred

    (Preferred, but not legally required for hire)
    Bilingual (Spanish)

    #J-18808-Ljbffr
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