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Real Staffing

Design Control QE

  • Job type: Contract
  • Salary: competitive
  • Location: Irvine
  • Reference: RE-32500766

Currently looking for a top level Quality Engineer who specializes with Design Control in the manufacturing process and new product development. This is a very exciting opportunity to work for one of the best Medical Device Companies in Irvine, CA.

My client is a Global Leading Medical Device Company that is looking for two Quality Engineers. The Quality Engineer, Design Control will be responsible to drive quality engineering processes and will be responsible for quality activities as part of a cross functional team that includes: R&D, Manufacturing, Production, Regulatory Affairs and other functions to drive technical decisions and project schedule.

The job duties for this role include:

* Providing design control expertise in product design and design iteration

* Managing Design History Files

* Manufacturing process and design support, including process validation, risk analysis and quality control plan development
* Maintaining regulatory and quality compliance

The requirements for the Quality Engineer are:

* A Bachelor's degree in engineering required, electrical or biomedical degree a plus
* Minimum 7 years of experience
* Medical device experience required, pharmaceutical industry experience will be considered
* FDA regulated experience
* Design control, change control and process qualification
* Design for manufacturing, quality method development, method validation
* Excellent communication skills, both written and spoken
* A strong sense of urgency and problem solving skills

If you're interested in these Quality Engineer roles please reply to the advert with your most up to date resume and a time that I can call you tomorrow

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