Quality Engineer - NPI

For immediate consideration, please apply directly to this job posting AND email me at biacosta  with the following:

1) word copy of resume

2) 2-3 professional references

3) 4-5 brief bullet points highlighting technical qualifications

Quality Engineer - NPI

As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership in quality assurance and control. Your role will be pivotal in supporting the development and introduction of new products, processes, and technologies, with a focus on quality systems development, regulatory compliance, and process risk management, including pFMEA. You will develop and characterize processes that are capable, scalable, and produce high yield, while also supporting the design of robust inspection strategies including CQA’s, CTQ’s, and MSA’s.

• Foster collaborative relationships across Design Divisions, Advanced Operations, and Quality functions for successful design transfer activities.
• Communicate effectively with internal customers, stakeholders, and project teams to achieve NPI project goals.
• Mentor other groups on design and process transfer expertise.
• Develop and implement methods for process control, improvement, testing, and inspection to ensure product quality.
• Analyze reports and defective products to identify trends and recommend corrective actions.
• Collaborate with supplier representatives on quality problems and contribute to supplier quality improvement programs.
• Apply risk management practices and tools, ensuring compliance with ISO
  14971.
• Develop and implement lean inspection strategies and plans using state-of-the-art methods and technologies.
• Lead continuous improvements of inspection methods and sampling plans.
• Support the development and execution of validation strategies to achieve highly capable processes.
• Provide expertise in statistical techniques to develop robust quality systems.
• Lead the supplier qualification strategy and approve supplier validations and PPAP.
• Represent quality assurance during the Design Transfer Agreement Plan process to ensure successful product launches.

• Bachelor of Science in Engineering or related subject.
• 3-5 years of experience in a quality or technical discipline.
• Proficiency in mechanical engineering, quality systems, manufacturing processes, and quality engineering.
• Experience in risk management, design control, and validation, particularly within the medical device sector.

• Knowledge of NPI processes and methodologies.
• Familiarity with medical device regulations and standards.

This position requires 100% onsite work in Irvine. The work environment is professional, and the role involves collaborating with various teams to ensure successful project outcomes.

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

• Pay range: $ - $/hr.
• 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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Mar 5, 2026.

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 actalentaccom (%20actalentaccom) for other accommodation options.