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Quality Engineer - NPI
role at
Actalent .
As a Quality Engineer for New Product Introduction (NPI), you will play a critical role in leading and advocating design for manufacture and assembly, providing technical leadership 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 NC’s & CAPA’s 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
Pay range: $55.00 - $70.00 per hour.
Benefits include medical, dental & vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; short and long‑term disability; health spending account; transportation benefits; employee assistance program; PTO, vacation or sick leave.
Application Deadline This position is anticipated to close on Oct 31, 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.
Employment Details
Seniority level: Mid‑Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Business Consulting and Services
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Quality Engineer - NPI
role at
Actalent .
As a Quality Engineer for New Product Introduction (NPI), you will play a critical role in leading and advocating design for manufacture and assembly, providing technical leadership 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 NC’s & CAPA’s 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
Pay range: $55.00 - $70.00 per hour.
Benefits include medical, dental & vision; critical illness, accident, and hospital; 401(k) retirement plan; life insurance; short and long‑term disability; health spending account; transportation benefits; employee assistance program; PTO, vacation or sick leave.
Application Deadline This position is anticipated to close on Oct 31, 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.
Employment Details
Seniority level: Mid‑Senior level
Employment type: Contract
Job function: Quality Assurance
Industries: Business Consulting and Services
#J-18808-Ljbffr