"Alerted.org

Job Title: Quality Engineer - NPIJob Description

As a Quality Engineer specializing in New Product Introduction (NPI), you will play a crucial role in advocating and leading 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, with an emphasis on quality systems development, regulatory compliance, and process risk management, including pFMEA. You will work to develop and characterize processes that are capable, scalable, and produce high yield, as well as support the design of robust inspection strategies.

Responsibilities

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

+ Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with high levels of quality.

+ Mentor other groups on design and process transfer expertise.

+ Develop and implement methods and procedures for process control, improvement, testing, and inspection to ensure products are flaw-free and function as designed.

+ Analyze reports and defective products to identify trends and recommend corrective actions.

+ Collaborate with supplier representatives to address quality problems and contribute to supplier quality improvement programs.

+ Proficiently manage risk using tools such as PFMEA and ensure risk management outputs comply with ISO14971.

+ Develop and implement lean inspection strategies and plans, ensuring inspections are repeatable, efficient, and scalable.

+ Lead continuous improvements in inspection methods and sampling plans to eliminate human error risks.

+ Support the development, execution, and approval of validation strategies aimed at achieving highly capable processes.

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

+ Represent quality assurance during the Design Transfer Agreement Plan (DTAP) process, ensuring product launches meet established metric targets.

+ Provide expert quality process support post-launch per DTAP agreement.

Essential Skills

+ Expertise in risk management practices and tools, especially PFMEA.

+ Experience with quality systems development and regulatory compliance.

+ Proficiency in developing and implementing inspection strategies and plans.

+ Ability to support validation strategies and ensure process scalability.

+ Strong communication skills for collaborating with internal and external stakeholders.

Additional Skills & Qualifications

+ Bachelor of Science in Engineering or a related subject.

+ 3-5 years of experience in a quality or technical discipline.

+ Proficiency in CQA, CTQ, ISO14971, MSA, and PFMEA.

+ Experience in overhauling production processes, including MVPs, PFMEAs, and value stream maps.

+ Understanding of Design Transfer, Manufacturing, Risk Management, and Medical Devices.

Work Environment

This is an onsite role, requiring presence 5 days a week. The position is an individual contributor role that demands independent judgment in applying professional expertise. Standard benefits include 3 weeks of PTO, 10 paid holidays, and comprehensive 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 Dec 19, 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.