Senior Design Quality Engineer

The Fountain Group is currently seeking a Manager, Design Quality for a prominent client of ours. This position is located in Lake County, IL
. Details for the position are as follows:

Pay Rate: $80-$100/hr

Duration: 12 months (Strong possibility for extension/conversion based on performance and budget)

Hybrid Role!!

Main Responsibilities:

• Responsible for representing QA on cross-functional teams and executing Quality System requirements to ensure products are properly transferred from development to manufacturing and maintained on market while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide.
• Primary driver for the quality and compliance aspects of product transfer and on-market change management.
• Serves as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of Client.
• Lead/support process validation activities (IQ/OQ/PQ/PPQ), including TMV.
• Mentor/lead product team members through the design transfer process providing guidance to assure optimal approach.

Qualifications:

• Bachelor's degree in engineering, science, or other technical areas;
  Advanced degree preferred; ASQ certification preferred (CQA, CQE, SSBB, etc.)
• 8+ years of relevant experience in the medical device or combination product industry is required.
• 5+ years of Quality Assurance experience required.
• Experience leading design controls and change controls is required.
• Experience with infusion pumps, PFS, Autoinjector, or On Body Injector is preferred.

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