Job Description
As a Quality Engineer focused on QMS & Design Control, you will play a pivotal role in advocating and leading design for manufacturing and assembly through technical leadership in quality assurance, control, and preventative activities. You will support the development and introduction of new products, processes, and technologies, ensuring compliance with quality systems, regulatory standards, and process risk management including pFMEA. Your role includes developing and characterizing scalable processes that yield high quality output and designing robust inspection strategies such as CQA’s, CTQ’s, and MSA’s.
ResponsibilitiesFoster collaborative relationships across Design Divisions, Advanced Operations, and GQO functions related to design transfer activities.Communicate effectively with internal customers, stakeholders, and project teams to ensure successful project transfers that meet NPI project goals.Mentor other groups on areas of expertise, especially in design and process transfer.Develop and implement methods for process control, improvement, testing, and inspection to ensure products are free of flaws.Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels.Analyze reports and defective products to determine trends and recommend corrective actions.Collaborate with supplier representatives on quality issues, ensuring effective corrective actions and contributing to supplier quality improvement programs.Proficiently apply risk management practices and tools, with expertise in failure modes associated with production processes.Support the Risk Management File through risk management principles and ensure compliance with ISO14971.Develop lean inspection strategies and plans through state-of-the-art inspection technologies.Lead continuous improvements in inspection methods and sampling plans.Lead First Article Inspection (FAI) strategies and approve inspections.Support the development and execution of validation strategies to ensure highly capable processes.Apply statistical techniques to develop robust, predictive quality systems transferable to production environments.Provide expertise in NC’s & CAPA’s related to new products and mentor in problem-solving tools.Support Design for Manufacture and Assembly through process design and inspection optimization.Lead supplier qualification strategy and approve supplier validations and Production Part Approval Process.Represent quality assurance during Design Transfer Agreement Plan (DTAP) process.Participate in internal and external audits with regulatory representatives.Ensure product launches meet established metric targets through robust NPI quality deliverables.Essential SkillsProficiency in ISO standards, particularly ISO14971.Expertise in Design Transfer and Manufacturing.Experience in Risk Management and PFMEA.Knowledge in Quality Engineering, Validation, and Design Control.Bachelor of Science in Engineering or related subject with 3-5 years’ experience in a quality or technical discipline.Additional Skills & QualificationsExperience in Medical Device validation and product transfer.Good experience overhauling production processes, including MVPs, PFMEAs, and value stream maps.Ability to work independently with minimal supervision.Capability to make judgments based on practice and previous experience.Work Environment
This position is onsite and offers a comprehensive benefits package including 2 weeks PTO, 10 paid holidays, and standard benefits. The work environment encourages independence, requiring judgement in applying professional expertise, and the ability to work autonomously with minimal supervision.
Pay and BenefitsThe 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 25, 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 actalentaccommodation@actalentservices.com for other accommodation options.