Job ID:

10326348 Posted today Back Irvine, CA, US Engineering Bachelors Degree Full Time, Temporary $58

$62/hr Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Irvine, CA, US $58
$62/hr Experienced (Non-Manager) Full Time, Temporary Biotechnology/Pharmaceuticals On-site Engineering Bachelors Degree First Shift (Day) Apply Now Applied Job details

New Product Introduction Quality Engineer Location:

100% ONSITE

Irvine, California (92618)

Type:

6 months Pay Rate

Negotiable depending on DIRECT
related experience UP to $58/hr
$62/hr Work Authorization
Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements

Job Summary:

The regional NPI QE team as part of GQO Quality Assurance organization with responsibility for quality assurance activities, including, but not limited to the following: Key Accountabilities

NPI QE Standard Work Collaboration with

R D, AO & GQO

throughout the NPI and overall product lifecycle Drive Process Risk Management activities Develop Effective Inspection processes Validation Quality Approver and, where certified, Validation Rep/Specialist Drive Process Excellence, pursuing validation over verification, where appropriate Own the NPI Purchasing Controls via PPAP and related efforts Design Transfer (in aggregate): Design and Process Transfer, Project Transfer General Responsibilities Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities. Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals. Mentor other groups on areas of expertise with particular attention to design and process transfer. Risk Management Effective in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA). Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle. Ensure all Risk Management outputs comply with

ISO 14971.

Support Design team to complete CQA/CTQ identification and inputs to dFMEA. Inspection Implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable. Lead continuous improvements of inspection methods and sampling plans, with a focus on human error risk elimination. Lead First Article Inspection (FAI) Strategies, both internally and externally, and approve First Article Inspections. Optimize inspection costs through lean initiatives while maintaining safety, integrity, and reliability of the product.

Must haves:

Collaboration with

R D, AO & GQO

throughout the NPI and overall product lifecycle Ability to drive Process Risk Management activities Development of Effective Inspection processes Nice to haves: Validation Quality Approver and, where certified, Validation Rep/Specialist Drive Process Excellence, pursuing validation over verification, where appropriate Own the NPI Purchasing Controls via PPAP and related efforts

Education:

B.S. in Engineering, Physical Sciences or Statistics. M.S., in the same disciplines, preferred. 3 years of professional experience, minimum, post academia.

Kelly does not expense relocation/interview costs.
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.

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$62/hr As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources.

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly ® Engineering? Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. 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