Senior Engineer, Quality Assurance Engineering

Location: Irvine, CA Salary: $65.00 USD Hourly - $74.00 USD Hourly Description: Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 6 month contract.

ROLE 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):

o Design and Process Transfer,

o 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.

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