Job Information
Actalent Quality Engineer - NPI in Irvine, California
Job Title: Quality Engineer - NPI
For immediate consideration, please apply directly to this job posting AND email me at biacosta @actalentservices.com with the following:
1) word copy of resume
2) 2-3 professional references
3) 4-5 brief bullet points highlighting technical qualifications
Job Description
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.
Responsibilities
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.
Essential Skills
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.
Additional Skills & Qualifications
CQA/CTQ
ISO
PFMEA
MSA
TMV
IQ/OQ/PQ validation
Quality engineering
Medical device validation
Design Control
Product Transfer
Work Environment
The role requires onsite presence five times a week. Employees enjoy 3 weeks of PTO, 10 paid holidays, and standard benefits.
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
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.
Application Deadline
This position is anticipated to close on Mar 18, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.