Quality Engineer - NPI

Job Title:

Quality Engineer - NPI

The NPI Quality Engineer plays a pivotal role in leading DFMA, quality assurance, and process risk management for the successful introduction of new products and technologies. This position focuses on developing capable, scalable manufacturing processes, robust inspection strategies, and ensuring smooth design transfer across cross‑functional teams, with the project running through February 2027.

• Lead quality engineering activities for new product development and design transfer.
• Implement methods for process control, improvement, testing, and inspection.
• Analyze defects, identify trends, and drive corrective and preventive actions with suppliers and internal teams.
• Lead process risk assessments (pFMEA) and ensure compliance with ISO standards.
• Support CQA/CTQ definition and linkage to dFMEAs to enable robust process characterization and control.
• Develop lean, scalable inspection strategies and sampling plans.
• Lead and approve First Article Inspections (FAI).
• Define and approve Measurement System Analyses (MSA) and Test Method Validation (TMV) to ensure repeatable, reliable measurement systems.
• Develop and approve validation strategies, including IQ, OQ, PQ, to establish highly capable, high yield processes.
• Incorporate TMV into validation planning to ensure test methods are accurate, repeatable, and appropriate for validation activities.
• Analyze validation data and approve protocols and conduct sterilization validation activities when necessary.
• Use statistical tools to develop predictive, reliable quality systems.
• Provide expertise in NC/CAPA investigations and root cause analysis.
• Support tooling, fixture design, and human error mitigation.
• Lead supplier qualification and PPAP activities.
• Ensure suppliers develop capable, scalable processes aligned with organizational expectations.
• Support supplier certification and quality agreements.
• Represent Quality during DTAP to ensure launches meet key quality and performance metrics.
• Participate in audits and design reviews; ensure completion of all NPI quality deliverables.
• Transfer lessons learned and support post‑launch quality activities.
• Maintain product control and containment during pre‑release builds.

• Bachelor’s degree in Engineering, Science, or related field.
• 3–5 years of experience in quality engineering or a related technical discipline.
• Strong independent judgment and applied technical expertise.
• Experience leading NPI quality deliverables end to end for multiple product launches.
• Ability to build or improve manufacturing processes from early prototype through ramp.
• Experience driving cross‑functional decisions with design, manufacturing, and suppliers.
• Execution of statistically sound validation and characterization work with clear evidence of process capability improvements.
• Management of quality readiness at suppliers including PPAP, FAI, and process controls.

• CQA/CTQ
• ISO
• PFMEA
• MSA
• TMV
• IQ/OQ/PQ validation
• Quality engineering
• Medical device validation
• Design Control
• Product Transfer

The role requires onsite presence five times a week. Employees enjoy 3 weeks of PTO, 10 paid holidays, and standard benefits.

This is a Contract position based out of Irvine, CA.

The pay range for this position is $55.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine, CA. Final date to receive applications This position is anticipated to close on Mar 19, 2026.

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