Quality Engineer – New Product Introduction (NPI)

Location: Irvine, CA (Onsite – 5 days per week)
Work Schedule: Monday–Friday, 8:00 AM–5:00 PM (1-hour lunch)
 

Position Summary

We are seeking a Quality Engineer to support New Product Introduction (NPI) activities within a regulated manufacturing environment. This role partners with cross-functional teams to support product development, design transfer, process validation, risk management, and inspection strategy throughout the product lifecycle.

The successful candidate will work closely with Engineering, Operations, Quality, and other stakeholders to help ensure manufacturing processes and quality systems support successful product launches and ongoing production.

Key Responsibilities

New Product Introduction

• Partner with Research & Development, Advanced Operations, and Quality teams throughout new product introduction and the product lifecycle.
• Support design transfer and process transfer activities from development into manufacturing.
• Participate in project transfer activities to help ensure manufacturing readiness.

Risk Management

• Lead or support process risk management activities, including Process Failure Mode and Effects Analysis (PFMEA).
• Evaluate manufacturing process risks and recommend mitigation strategies.
• Help establish and implement production controls throughout the manufacturing lifecycle.
• Support Risk Management documentation in accordance with ISO 14971.
• Collaborate with design teams on Critical-to-Quality (CTQ) characteristics and Design FMEA inputs.

Inspection & Quality Systems

• Develop and implement effective inspection plans and inspection processes.
• Improve inspection methods to increase repeatability, efficiency, and scalability.
• Support continuous improvement initiatives focused on reducing inspection-related risk and human error.
• Lead or support First Article Inspection (FAI) planning and approval activities.
• Identify opportunities to improve inspection efficiency while maintaining product quality and compliance.

Process Validation & Quality

• Support validation activities as a Quality representative or approver, when qualified.
• Promote process improvements that emphasize validated manufacturing processes where appropriate.
• Support New Product Introduction purchasing controls, including Production Part Approval Process (PPAP) activities.

Cross-Functional Collaboration

• Build effective working relationships across Engineering, Operations, Quality, and external partners.
• Communicate project status and quality requirements with stakeholders.
• Share knowledge and provide guidance on design transfer and manufacturing quality practices.

Required Qualifications

• Bachelor's degree in Engineering, Physical Sciences, Statistics, or a related technical discipline.
• Minimum of 3 years of professional engineering or quality experience after completing academic studies.
• Experience collaborating with cross-functional teams during new product introduction or product lifecycle activities.
• Experience with process risk management methodologies, including PFMEA.
• Experience developing or improving inspection processes in a manufacturing environment.

Preferred Qualifications

• Master's degree in Engineering, Physical Sciences, Statistics, or a related discipline.
• Experience supporting process validation as a Quality representative or approver.
• Familiarity with Production Part Approval Process (PPAP).
• Experience driving process improvement initiatives within a regulated manufacturing environment.
• Knowledge of ISO 14971 risk management requirements.