Quality Engineer

Job Requisition: 6790

Quality Engineer (Direct Hire)

Greater Milwaukee Area, WI

Job Requisition: 6790

Description for Quality Engineer:

The Quality Engineer is responsible for maintaining the Quality Management Systems ensuring product compliance to internal and customer specifications as well as compliance to Client processes. Additionally, they will be responsible for ensuring that new products meet all customer and Client 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.

Our Client 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.

Responsibilities for Quality Engineer:

  • 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’s 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 Client processes as well as requirements imposed upon Client 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.

Requirements for Quality Engineer:

  • 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.

 

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