Inginaire - Engineering Staffing

Quality Engineer

Location
Bloomington, MN
Salary
Contact For Rate
Posted
Jul 24, 2019
Closes
Aug 31, 2019
Ref
816504
Category
Engineering
Job Type
Employee
Employment Status
Full Time
Inginaire is looking for a Quality Engineer to support all phases of the Quality Management System for our client in Bloomington, MN. The ideal candidate is an energetic Quality Engineer with strong attention to detail and the ability to balance and prioritize multiple demands. This position will lead, coach, monitor and drive actions in the incoming inspection and materials to assure incoming components meet specifications and available for production, suppliers are performing to QTS standards and the team is working efficiently. This is a direct hire opportunity!

Duties

  • Oversee Inspection processes and Inspection quoting, including supervision and technical support for Receiving inspectors.
  • Perform QA review and approval of documentation for products.
  • Validates incoming inspection processes as required, through Test Method Validation and Gage R & R.
  • Supports customer requirements for Test Method Validation and Gage R &R internal at sub-tier suppliers.
  • Lead environmental monitoring and equipment CAPAs.


Skills and Experience

  • Four-year degree in technical field preferred.
  • Proficient in the use of GD&T
  • Knowledge or training pertaining to FDA and ISO regulations.
  • Knowledge in working with Root Cause Analysis, using quality tools such as Fish Bone Diagramming, Flow Charting and Value Streaming.
  • Experience programming smart scope or CMM.
  • ISO 13485, FDA 21 CFR 820, MN Board Pharmacy Regulations.
  • 2 years medical manufacturing environment experience in a quality-related position preferred.

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