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    Principal Quality Engineer - Lansing, United States - Endo

    Endo
    Endo Lansing, United States

    2 days ago

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    Description
    Why Endo?


    We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution.

    Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

    Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.


    At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.


    The Principal Quality Engineering Independently supports the most complex projects, collaborating with other quality, engineering, and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating and reviewing internal investigations, CAPAs, and change controls.

    Leads multi-functional teams in special, highly sensitive, and/or cross-site projects. Leads investigations, corrective actions, continuous improvement projects, and process capability improvements. Coaches personnel across departments in quality processes and mentors more junior Quality Engineers in the use of decision-making tools.

    Validation & Qualification
    Independently supporting the most complex projects, collaborates with other quality, engineering, and manufacturing operations functions ensure all quality aspects of validation and qualification activities at the site including process validation, facility qualification, equipment validation (URS), IQ, OQ and PQ
    Reviews and may approve the generation and maintenance of validation/qualification protocols and Validation Master Plans
    40%

    Analysis
    Demonstrates break-through thinking to solve complex problems
    Leads multi-functional teams in special, highly sensitive, and/or cross-site projects
    Mentors more junior Quality Engineers in the use of decision-making tools
    Performs statistical analysis for the identification of trends
    Collaborates with other departments to implement improvements
    30%

    Compliance
    Coaches personnel across departments in quality processes
    Provides subject matter expertise to support other departments (e.g. change controls, SOPs, CAPAs, investigation etc.) to ensure compliance with cGMPs
    Reviews and approves engineering Change Controls
    Collaborates with other departments to ensure quality standards are in place
    Leads investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.)
    Authors/revises department SOPs that reflect current practices and are in compliance with FDA and other regulatory requirements and guidances
    25%

    Metrics
    Presents data at Management Reviews
    5%

    Qualifications
    Education & Experience
    BS in Engineering, Science, or equivalent plus a minimum of 10+ years of relevant experience. Advanced degree a plus

    Knowledge
    Knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools

    Skills & Abilities
    Ability to lead teams
    Ability to coach personnel across departments and to mentor other Quality Engineers
    Ability to display and analyze data in a logical manner
    Good communication skills, including reading and understanding technical instructions
    Good attention to detail
    Solid organizational skills
    Ability to take initiative, set priorities and follow through on assignments

    Physical Requirements
    Ability to stand for up to 8 hours
    Ability to wear personal protective equipment, including respirators, gloves, etc.
    Manual dexterity
    Ability to lift and carry 15 lbs.

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