Senior Engineer, Quality Assurance Engineering

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Designs and installs sophisticated testing equipment and performs product testing and analysis to maintain quality levels and minimize defects and failure rates. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

Onsite 5 days a week in Irvine, CA
Shift: 8:00am to 5:00pm, 1.0 hour lunch. Overtime support is not intended.
Target start date: Monday, 10 Aug 2026. Earlier desired, if possible.

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.

Interview process:
1-2 rounds
Teams meeting with HM

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