Quality Engineer - NPI

Quality Engineer - NPI - New Product Introduction / Medical Device

Job Description

As a Quality Engineer specializing in New Product Introduction (NPI), you will lead and advocate for design for manufacture and assembly through technical leadership in quality assurance and control. Your focus will be on quality systems development, regulatory compliance, and process risk management, including pFMEA. You will support the development and introduction of new products, processes, and technologies, ensuring they are capable, scalable, and produce high yields. Additionally, you will design robust inspection strategies and provide quality engineering support during design transfer phases.

Responsibilities

n
• n

  Foster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions.

  n
n
• n

  Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers.

  n
n
• n

  Mentor other groups on design and process transfer expertise.

  n
n
• n

  Develop methods for process control, improvement, testing, and inspection to ensure product quality.

  n
n
• n

  Analyze reports and defective products to recommend corrective actions.

  n
n
• n

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

  n
n
• n

  Proficiently manage risk using tools like pFMEA and ensure compliance with ISO14971.

  n
n
• n

  Support design team in completing CQA/CTQ identification and dFMEA inputs.

  n
n
• n

  Develop lean inspection strategies and ensure repeatable, efficient, and scalable inspections.

  n
n
• n

  Lead First Article Inspection strategies and approve inspections.

  n
n
• n

  Support validation strategies for scalable, high-yield processes.

  n
n
• n

  Promote human factor error prevention and provide expertise in error risk identification.

  n
n
• n

  Lead supplier qualification strategy and influence the selection of suppliers.

  n
n
• n

  Represent quality assurance in the Design Transfer Agreement Plan process.

  n
n
• n

  Provide quality process support post-launch and ensure robust NPI quality deliverables.

  n
n

Essential Skills

n
• n

  Bachelor of Science in Engineering or related discipline.

  n
n
• n

  3-5 years’ experience in a quality or technical role.

  n
n
• n

  Proficiency in risk management practices and tools like PFMEA.

  n
n
• n

  Experience in quality engineering, validation, and design control.

  n
n
• n

  Understanding of ISO14971 and experience with medical devices.

  n
n

Additional Skills & Qualifications

n
• n

  CQA/CTQ experience.

  n
n
• n

  Experience with MSA, PFMEA, and design transfer.

  n
n
• n

  Ability to overhaul production processes, including MVPs, PFMEAs, and value stream maps.

  n
n
• n

  Independent work capability with minimal supervision.

  n
n
• n

  Judgment based on practice and previous experience.

  n
n

Work Environment

This position requires on-site work, no hybrid / remote work available. Standard benefits include two weeks of PTO and ten paid holidays. The role involves individual contributions and requires a university degree or equivalent experience. The work environment emphasizes collaboration and independent problem-solving.

Job Type & Location

This is a long-term 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:

• 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 Oct 23, 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.