Quality Engineer - NPI

Job Title: Quality Engineer - NPIJob Description As a Quality Engineer for New Product Introduction (NPI), you will play a critical role in leading and advocating design for manufacture and assembly. You will provide technical leadership and direction in quality assurance, quality control, and preventative activities. Your focus will be on supporting the development and introduction of new products, processes, and technologies while ensuring quality systems development, regulatory compliance, and process risk management. Responsibilities + Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions for successful design transfer activities. + Communicate effectively with internal customers, stakeholders, and project teams to ensure project transfers meet NPI project goals with the highest quality. + Mentor various groups on expertise areas, particularly on design and process transfer. + Develop and implement methods for process control, improvement, testing, and inspection to ensure defect-free products. + Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels. + Analyze reports and defective products, recommending corrective actions. + Collaborate with suppliers to resolve quality problems and contribute to supplier quality improvement programs. + Proficiently manage risk through tools like PFMEA and ensure compliance with ISO14971. + Support design teams in CQA/CTQ identification and inputs to dFMEA for robust process control. + Develop and implement lean inspection strategies, ensuring inspections are repeatable and efficient. + Lead continuous improvements in inspection methods, focusing on eliminating human error risks. + Lead and approve First Article Inspection (FAI) strategies. + Optimize inspection costs through lean initiatives while maintaining product safety and reliability. + Support and approve validation strategies, influencing processes toward validation over manual verification. + Apply statistical techniques to develop robust, predictive quality systems. + Provide expertise for NCu2019s & CAPAu2019s related to new products, acting as a subject matter expert. + Lead supplier qualification strategy and approve supplier validations and PPAP. + Represent quality assurance during the DTAP process, ensuring product launches meet established targets. Essential Skills + Expertise in ISO standards, Design Transfer, and Manufacturing. + Proficiency in Risk Management and PFMEA. + Experience in Quality Engineering, NPI, Validation, Medical Device, and Product Transfer. + Bachelor of Science in Engineering or a related field with 3-5 years of experience in a quality or technical discipline. Additional Skills & Qualifications + Familiarity with CQA, CTQ, ISO14971, MSA, and PFMEA. + Experience with overhauling production processes, including MVPs, PFMEAs, and value stream maps. Work Environment This role is based onsite five days a week. It is an individual contributor role requiring independent work with minimal supervision. Employees enjoy two weeks of PTO, 10 paid holidays, and standard benefits. Job Type & Location This is a Contract position based out of Irvine, California. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 Oct 24, 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 ( ) for other accommodation options.

Created: 2025-10-15