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Job Title: Quality Engineer - NPIJob Description

In this role, you will lead the design for manufacture and assembly by providing technical leadership and guidance in quality assurance, quality control, and preventative activities. You will support the development and introduction of new products, processes, and technologies with a focus on quality systems development, regulatory compliance, and process risk management. Your role involves developing and characterizing processes that are capable, scalable, and produce high yield, while also designing robust inspection strategies.

Responsibilities

+ Foster collaborative internal and external professional relationships across design divisions and functions related to design transfer activities.

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

+ Mentor other groups on design and process transfer expertise.

+ Develop and implement methods for process control and improvement to ensure product quality.

+ Collaborate with suppliers to address quality issues and contribute to supplier quality improvement programs.

+ Manage risk by employing risk management practices and tools, with a focus on failure modes and process controls.

+ Ensure compliance with ISO14971 standards and support the design team in risk identification and mitigation.

+ Develop and implement lean inspection strategies and lead continuous improvements in inspection methods.

+ Lead and approve validation strategies and influence processes towards validation.

+ Apply statistical techniques to develop robust quality systems and provide expertise for non-conformances and corrective actions.

+ Lead supplier qualification strategies and support the implementation of supplier certification.

+ Represent quality assurance in design transfer processes and ensure product launches meet established targets.

Essential Skills

+ Proficiency in risk management and PFMEA

+ Experience with validation and quality engineering in medical devices

+ Knowledge of ISO14971 and design transfer processes

+ Bachelor of Science in Engineering or related field with 3-5 years of experience in a quality or technical discipline

Additional Skills & Qualifications

+ Experience in developing inspection strategies and using measurement system analysis (MSA)

+ Knowledge in CQA and CTQ processes

+ Ability to overhaul production processes and align procedures

Work Environment

This position requires working onsite. The role is an individual contributor position that requires independent work with minimal supervision. Standard benefits are offered, including 2 weeks of PTO and 10 paid holidays.

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 Jul 30, 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.