Senior Quality Engineer

Senior Quality Engineer

Location:

Menomonee Falls, WI

Posted:

05 May 2022

Job ID:

cd9e855f-978b-ec11-93b0-000d3a8abbf6

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JOB SUMMARY:
Under minimal direction, directs all activities related to inspection-measuring equipment and other inspection tools.  PPAP support is required for New Product Development and legacy purchased part changes. Lead all internal Material Review Board (MRB) activities and comply with the documentation and process requirements. Support the Quality Department’s objectives to increase product quality and awareness throughout the manufacturing area(s). The expectations would be to address quality issues as they surface, and work with the appropriate personnel to resolve non-conformances. Some ISO 9001/13485 activities will be assigned per the internal audit schedule. The Senior Quality Engineer would have direct reporting responsibility to the Director of Quality.    
 
JOB DUTIES:
  • Support assigned departments in maintaining the highest quality disciplines and requirements outlined in the Quality Manual and Policy
  • Manage MRB / RTV processes for assigned Value Stream(s)
  • Manage the internal calibration program
  • Support internal auditing activities as Lead Auditor
  • Lead Layered Process Audits and countermeasures for unfavorable results
  • Support inspection of raw materials / purchased parts when needed
  • Prepare reports by collecting, analyzing, and summarizing data; making recommendations
  • Initiate corrective actions and provide support to complete 8 Step / 4 Step / LDM process
  • Support PPAP inspection and NPD validation when required
  • Inspect internal fabrication parts for audit / compliance requirements as needed
  • Implement continuous improvements for key projects (Kaizen, Behag, etc)
  • Monitor and suggest improvement changes related to drawings, specifications and material requirements
  • Respond to daily quality issues (fabrication/assembly/cycle test/inventory rejects) 
  • Support supplied component troubleshooting and non-conforming product communication to Purchasing
  • Provide general guidance for third party rework activities
  • Support acceptance criteria requirements (visual aids, standard)
  • Other project work as assigned
EDUCATION / SKILLS REQUIRED:
  • Bachelors Degree in Engineering or related field  
  • Excellent interpersonal skills 
  • Effective verbal & written communication skills
  • Effective organizational and planning skills
  • Robust problem-solving techniques and ability to develop creative ideas and solutions
  • Strong analytical skills.  Ability to understand and communicate basic technical information both internally & externally
  • Able to accumulate and analyze data to identify and resolve problems
  • Able to read engineering drawings, electrical schematics, and wiring diagrams
  • Ability to understand and communicate basic technical information
  • Internal auditing experience
  • Basic computer skills including Microsoft Office are necessary, as documentation and record keeping is essential Complaint Handling experience a plus
  • ASQ CQE - Certified Quality Engineer preferred
  • 3-5 years experience in manufacturing environment required
  • Experience in 21 CFR 820 and ISO 13485 is a plus
cd9e855f-978b-ec11-93b0-000d3a8abbf6

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