Quality Engineer

MGS United States
posted 2 months ago
Germantown, Wisconsin, United States View on Map
Published : October 7, 2022
Apply Before : December 30, 2022
Job Description
  • Job Tracking ID :¬†512093-832859
  • Job Level :¬†Mid Career (2+ years)
  • Level of Education :¬†BA/BS
  • Job Type :¬†Full-Time/Regular
  • Date Updated :¬†10/03/2022
  • Years of Experience :¬†2 – 5 Years

Job Description

MGS Mfg. Group has an exciting opportunity for a full-time Quality Engineer within our Molding Division at our facility in Germantown, WI.  The Quality Engineer is responsible for maintaining the Quality Management Systems ensuring product compliance to internal and customer specifications as well as compliance to MGS processes. Additionally, they will be responsible for ensuring that new products meet all customer and MGS quality and documentation requirements when they are launched into production.  This is accomplished by developing and validating measurement systems, establishing in-process quality plans, validating production processes, submitting documentation for customer approval, and transferring knowledge.

MGS Mfg. Group is a best-in-class custom manufacturer that delivers plastics solutions in tooling, molding, and equipment technologies to help customers around the world bring innovative products to market.

We pride ourselves on being the best at what we do and look for individuals that have the same passion! We have a global footprint and our employees are a vital part of our success. We maintain and reinforce an atmosphere of mutual respect and communication that will foster continued growth and career opportunities. Our achievements are built on a solid foundation of core values that inspire a culture of Teamwork, Integrity, Passion, and Safety. To learn more visit us at www.mgsmfg.com.

Below are the essential duties and responsibilities:

  • Address customer complaints and internal quality issues.
    • Initiate the corrective action process and use the appropriate quality tools to ensure that the problem is satisfactorily resolved.
    • Investigate issues and acquire input from subject matter experts.
    • Interface with customers.
    • Drive the team to implement permanent corrective actions.
    • Update production documents including control plan, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
    • Record all actions on internal and customer-specific documentation, including updating customer portals.
  • Address suspect and non-conforming product.
    • Initiate stop-ship and containment activities.
    • Initiate RMA process for product in customer‚Äôs possession.
    • Recommend disposition of product.
    • Develop inspection/sort/rework instructions.
    • Develop customer waiver (deviation) documentation and obtain customer approval, if required.
  • Maintain the Quality Management System (QMS).
    • Understand ISO-9001 Quality management systems – Requirements.
    • Ensure continuing compliance to both internal MGS processes as well as requirements imposed upon MGS by certification bodies, regulatory agencies, and specific customer requirements. See below for additional requirements for automotive and medical products.
    • Perform Layered Process Audits.
    • Assist in 2nd¬†party, 3rd¬†party, and internal audits.
    • Assist in responses and corrective actions for audit findings.
  • Approve product for shipment.
    • Perform batch record reviews.
    • Generate Certificate of Analysis, as required.
    • Release product in ERP system.
  • Support engineering change process.
    • Interface with customer to ensure compliance to customer request and requirements.
    • Manage product inspection and testing activities.
    • Update production documents including control plans, PFMEA, visual inspection criteria, incoming inspection plan and in process inspection report.
    • Complete required documentation.
    • Submit documents to customer and obtain customer approval.
  • Support Operations.
    • Resolve inspection issues to allow product movement in a timely manner.
    • Update production documents when errors are found.
    • Train production and QC staff on customer requirements, inspection techniques, and rework instructions.
  • Understand ISO-13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
  • Understand 21 CFR Part 820 Quality System Regulation – Good Manufacturing Practice for the Medical Devices.
  • Understand cleanroom gowning practices and cleanliness requirements for manufacturing within a cleanroom.
  • Understand medical customer-specific requirements.
  • Any other duties as assigned.

Experience and Skills

A qualified candidate would fulfill these requirements:

  • BS degree in engineering or business.
  • Three to five years of experience and/or training, or equivalent combination of education and experience.
  • Demonstrated experience in problem solving.
  • Demonstrated statistical analysis skills.
  • GD&T experience.
  • Experience in working with teams to achieve results.

Why you should apply:

  • Great Benefits
  • 401K Match
  • Paid Holidays
  • Growth and Advancement Opportunities
  • Excellent Teamwork and culture
Job Detail
  • Experience 3-5 years experience
  • Education Bachelor's degree