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Job Title: Quality Engineer - NPI

Job Description

As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly, focusing on quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies with an emphasis on quality systems development, regulatory compliance, and process risk management.

Responsibilities

+ Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions associated with design transfer activities.

+ Communicate effectively with internal customers, stakeholders, and project teams to deliver successful project transfers meeting 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 products are flawless and function as designed.

+ Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality and minimize defects.

+ Collaborate with supplier representatives on quality issues and contribute to supplier quality improvement programs.

+ Proficiently manage risk practices and tools, focusing on production and production-related processes (PFMEA).

+ Support the Risk Management File through risk Management Principles.

+ Ensure compliance with ISO14971 and support design team in completing CQA/CTQ identification.

+ Develop and implement lean inspection strategies and plans through advanced inspection methods and technologies.

+ Lead continuous improvements of inspection methods and sampling plans.

+ Lead First Article Inspection strategies and approve First Article Inspections.

+ Optimize inspection costs while maintaining product safety, integrity, and reliability.

+ Support validation strategies for highly capable processes resulting in high yield and scalability.

+ Apply statistical techniques to ensure the development of robust, predictive quality systems.

+ Provide expertise for NC's & CAPA's related to new products.

+ Lead supplier qualification strategy and approve supplier validations and Production Part Approval Process (PPAP).

+ Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process.

+ Participate in internal & external audits with regulatory representatives.

+ Represent NPI Quality Assurance at Design reviews and ensure integrity of process design.

+ Support device design into production specifications.

Essential Skills

+ Bachelor of Science, Engineering or related subject with 3-5 years’ experience in a quality or technical discipline.

+ Proficiency in ISO standards, Design Transfer, Manufacturing, Risk Management, and PFMEA.

+ Experience in Validation, Quality Engineering, Medical Devices, Design Control, and Product Transfer.

+ Strong understanding of CQA, CTQ, ISO14971, MSA, and PFMEA.

Additional Skills & Qualifications

+ Good experience in overhauling production processes, including MVPs, PFMEAs, value stream maps, and procedure alignment.

Work Environment

This role is based onsite, providing a collaborative and dynamic work environment. Employees enjoy benefits such as 2 weeks of PTO, 10 paid holidays, and standard benefits.

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 Aug 15, 2025.

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 [email protected] (%[email protected]) for other accommodation options.