Quality Assurance Engineering
Onsite in Irvine, CA
Pay : $65 - $70.81/hr.
Duration: 6+ months, Contract, W-2
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:
Duties:
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 and Process Transfer, Project Transfer
* 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.
Qualifications:
* B.S. in Engineering, Physical Sciences or Statistics. M.S., in the same disciplines, preferred. 3 years of professional experience, minimum, post academia
* 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
* 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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.