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Quality Engineering Manager

Req ID: J2265903

  • Location
    Gurnee, Illinois, United States of America
  • Category Quality Group
  • Posted Wednesday, March 24, 2021
  • Type Full time

Job Description


In partnership with the site Quality Manager, carry out the Quality Engineering function for the site.  Accountable and responsible for ensuring best practices pertaining to the use of quality tools are developed and deployed at the site.  Establish product and process quality requirements.  Serve as a liaison between the Quality function, other site functional groups, and the customer in ensuring quality requirements are met and documented.  Plans, executes, and implements Quality Engineering activities for all new product/process introductions and changes to existing products/processes.  Executes major quality initiatives / projects at the direction of the site Quality Manager.  Investigates problems and recommends corrective actions for recurring and non-recurring discrepancies.  Creates motivating environment and empowers others.  Assists in building cohesive teams, bringing out the best from team members while fostering teamwork and collaboration. 


  • Identifies and manages performance through daily, weekly, monthly metrics, with clear stakeholder communication and issues elevation.
  • Applies systematic technical problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Identifies, plans, and executes quality requirements resulting from internal and external changes.
  • Uses the Quality Management System (QMS) in developing and executing the appropriate processes for consistent, technical, risk-based decision making.
  • Leads product introductions and supply chain continuity.
  • Servant leader to direct reports to include establishing individual goals & objectives, provide regular performance feedback, and support employee development & training.
  • Assists in the hiring and training of departmental staff and activities to ensure high performance, accountability, interdependence, and collaboration.
  • Develops new and/or improved techniques for engineering tasks.
  • Provides oversight in the development of validation protocols, reports, inspection plans, First Article Inspections, In-Process and Final Product Inspection, and Sampling Plans.
  • Minimizes customer complaints due to product quality through effective corrective and preventive actions.
  • Ensure compliance of project activities to appropriate standards and regulations (FDA, ISO, etc.).
  • Compile, document and interpret data required to monitor and analyze process related performance.
  • Support the development and/or implementation of site, customer, lean, or global quality initiatives with the use of project management methods and tools.
  • Ensure corrective actions are documented, implemented, verified effective, and submitted on time.
  • Adheres to all safety rules.
  • Perform other duties and responsibilities as assigned.


  • Experience in creating & implementing quality systems & cGMP validation protocols.
  • Experience in internal, supplier, third-party & FDA quality audits / inspections.
  • Able to assess and recommend improvements to manufacturing environment.
  • Strong knowledge of Quality Management System, 21 CFR Part 820/210/211 & ISO 13485:2016.
  • Ability to learn plastic injection molding and final device assembly SOPs.
  • Must be able to interact with customers in a professional manner both orally and in written communication.
  • Excellent problem-solving abilities.
  • Strong analytic skills and multitasking abilities as well as identifying and resolving issues with limited supervision.
  • Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.


  • BA/BS preferred.
  • 5 years experience in quality related field.
  • Additional 2 years managerial experience.
  • Or a combination of education, experience and/or training.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or by calling 1.727.803.7515 with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address and/or phone number.

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