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Engineer Sr., Quality

Company: Experis
Location: Minnetonka
Posted on: May 5, 2021

Job Description:

Hello, I am reaching out as you have been in touch with Experis previously and I am hoping that you might have contacts in your professional network who might be interested in an exciting new opportunity. I would like share some of the details of the role we are currently hiring for. It is a 10+ months contract as Sr Quality Engineer located in Minnetonka, MN with a major medical device company. I have included the detail of the opportunity below for your review. If you are not in the market for a new opportunity, please let me know if you have someone that might be a good fit. I appreciate you taking the time to review this, and I hope to hear from you soon. Job Title: Sr Quality Engineer Location: Minnetonka, MN Duration: 10+ Months (possibly extension) Job Descriptions:

  • Experience in medical device change controls and impact evaluations and product lifecycle management.
  • Experience with PFMEA and Process Validation, including Inspection Method validation activities.
  • Excellent written and verbal communication skills, ability to work in a team environment with technicians and engineers.
  • Senior QE Equivalent
  • Strong experience with medical device design and manufacturing change control
  • Sound medical device quality system understanding
  • Basics of Quality Systems: ISO 13485 / 21CFR820 + experience using quality systems DHF / DMR Basics (validation documents, manufacturing and design specification understanding and interpretation)
  • Experience in process validation (IQ/OQ/PQ), inspection validation, and process risk analysis (PFMEA / PFMECA)
  • Excellent Communication: o In-person with support / operations team to convey technical details
  • Written / remote communication to cross functional teams in various locations
  • Confident / Independent - support project as primary quality engineering support contact. Able to make sound decisions based on data available while complying to quality system requirementsRegards, Kushagra Mohan I Talent Acquisition Specialist Experis CORE , Ext:7165 100 Manpower Place - Milwaukee, WI 53212

Keywords: Experis, Minnetonka , Engineer Sr., Quality, Engineering , Minnetonka, Minnesota

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