Quality Engineer

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Lansing, MI, USA
In-Office
Biotech • Pharmaceutical
The Role

It's fun to work in a company where people truly believe in what they are doing!

Summary: Manages, coordinates and actively participates in activities related to all Quality System functions such as audits, corrective actions, process and equipment validations, supplier quality and general documentation management to ensure effective, efficient compliance with ISO/FDA quality management system principles and customer expectations specific to Neogen’s Food Safety Division.

At Neogen Corporation, we believe in fostering a culture of innovation, collaboration, and continuous improvement. As a Quality Engineer you will have the opportunity to work alongside talented professionals who are passionate about making a difference in the world. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development. Join us in our mission to protect and enhance global food and animal safety!

This role follows an onsite model to accommodate business needs while maintaining team collaboration.

Summary: Manages, coordinates and actively participates in activities related to all Quality System functions such as audits, corrective actions, process and equipment validations, supplier quality and general documentation management to ensure effective, efficient compliance with ISO/FDA quality management system principles and customer expectations specific to Neogen’s Food Safety Division.

Essential Duties and Responsibilities:

  • Ability to define and understand quality terms, definitions, concepts and processes. Must be able to apply quality tools, including continuous improvement techniques, problem solving and lean concepts.

  • Must be able to interpret information and data. Familiar with statistical terminology and techniques. Must be able to collect data for specific techniques. Must be able to interpret control chart results, process capability and specification limits. Ability to use data to report leading indicators.

  • Must have calibration/qualification knowledge, understand measurement and test equipment tools for various applications and how to assess tool accuracy and precision. Must understand the concept of calibration standards and traceability.

  • Must understand and apply inspection concepts, techniques and processes. Able to understand sample characteristics, types, and selecting samples from lots. Able to identify and segregate non-conforming material and be familiar with material review process.

  • Able to understand, apply and communicate various quality audit types and their components, tools and techniques. Able to apply quality tools and process improvement techniques while performing internal and external audits. Appraise process during audits using process performance indicators.

  • Understand risk assessment and mitigation. Must be able to apply the elements of corrective actions, such a prevention, root cause analysis, failure mode and effects analysis (FMEA), and the control of non-conforming products.

  • Review and approve root cause and actions planned and perform effectiveness checks for corrective actions.

  • Know the Plan-Do-Check-Act (PDCA) cycle and understand process concept.

  • Identify continual improvement actions, plan assessments, collect audit evidence and explain continual improvement to others. Help develop measurement systems to determine organizational improvement.

  • Must be able to identify and execute various process, equipment and cleaning validation and qualification methods. Development of validation protocols associated with equipment installation and new processes.

  • Other duties as may be assigned by management

Qualifications and Experience:

  • Minimum BS degree in Quality Management, Engineering, Biochemistry, Chemistry, Microbiology (Preferred), Food Science or other applicable degree.

  • 5+ years' experience in higher level functions supporting a Quality System in an ISO/FDA regulated environment.

  • Solid understanding of interaction between compliance and business needs/functions required.

  • ASQ Quality Engineer certification considered a plus.

  • Proficiency in the use of statistical software such as Minitab

Please press Apply to submit your application.

    Come Be Part Of A Mission that Matters!

    From inside the farm gate to our dinner plates, Neogen protects the world’s food supply. Through a variety of animal healthcare products, to food safety solutions for dangerous bacteria, allergens, toxins, drug residues and much more, Neogen is there — and you can be too.

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    The Company
    HQ: Lansing, MI
    1,160 Employees
    Year Founded: 1982

    What We Do

    NEOGEN Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. NEOGEN’s Animal Safety Division markets a complete line of diagnostics, veterinary instruments, veterinary pharmaceuticals, nutritional supplements, disinfectants and rodenticides.

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