Quality Engineer - Edison - MTF

    MTF
    MTF Edison

    2 days ago

    $80,000 - $145,000 (USD) per year *
    Description

    Overview

    MTF Biologics processes tissue grafts from human donors that are used in a growing array of clinical applications – positively affecting lives across the globe. As a global nonprofit organization that saves and heals lives by honoring donated gifts and serving patients, we collaborate with the medical, scientific, as well as organ and tissue donation communities.

    Our goal is simple–do what's right for patients, surgeons, tissue donors, and their families through our guiding principles.

    The Quality Engineer supports the validations of a designated business unit, including the planning, writing and data analysis for validations. The QE uses technical writing skills, statistics and other tools to implement products and processes to support production and laboratories.

    Mon-Fri, 8:15AM-4:30PM

    Responsibilities

    • Plan validation scope and requirements for product and process launches
    • Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated.
    • Perform data analysis that includes use of statistical tools, trending, capability analysis, sampling plans, ability to perform correlation analysis and other calculations as required.
    • Perform risk assessments independently and as a team applying techniques including Hazard Analysis per ISO 14971
    • Coordinate with internal and external personnel for standards, data, testing.
    • Perform other duties as assigned(exempt)(non-exempt)

    Qualifications

    MINIMUM JOB REQUIREMENTS

    Education:

    Bachelor of Science in engineering or scientific field

    Experience:

    3 years of validation experience in a regulated industry

    Specific Licenses and/or Certifications:

    Specialized Knowledge, Skill, and Abilities:*

    Basic statistics (ANOVA, t-test), Fluent in Microsoft Office, specifically Word and Excel, Strong verbal and written communication skills

    Work Environment:

    Office Environment, Laboratory Environment and Occasional Clean Room Access

    Physical Demands:

    ( if applicable)

    • Be able to lift 25 lbs infrequently, travel up to 20% of the time
    • Ability to gown in clean room environment

    PREFERRED QUALIFICATIONS

    Education:

    Bachelor's Degree in Biomedical or Chemical Engineering; Master's Degree in Engineering or Science

    Experience:

    3-5 years of validation experience in a regulated industry

    Specific Licenses and/or Certifications:

    CQE

    Specialized Knowledge, Skill, and Abilities:

    • Working knowledge of statistics including the use of statistical software (Excel, MiniTab)
    • Working knowledge of cell biology, microbiology or other biological science

    Benefits Information

    At MTF Biologics we provide comprehensive benefits and resources to support our employees physical, emotional, and financial health.

    • 4 weeks Paid Time Off (PTO)
    • Paid Holidays
    • Medical, Dental, Vision Insurance and Prescription Drug Insurance
    • 401K plan with company match
    • Short & Long Term Disability
    • Life & Accidental Death Insurance
    • Tuition Reimbursement
    • Health Care/Dependent Care Flexible Spending Accounts
    • Adoption Assistance
    • Voluntary Benefits (e.g., Pet Insurance, Legal, home and auto insurance)
    • Sword Health (at home Physical Therapy)

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    Job Location US-NJ-Edison

    Type Full-Time

    Category Quality

    Shift Non-Shift (Standard Business Hours 8:15am-4:30pm EST)

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