Job Title: Quality Engineer - NPI

** For Immediate consideration please apply to this posting and email your resume to habels@actalentservices.com**

Job Description

As a Quality Engineer specializing in New Product Introduction (NPI), you will advocate and lead design for manufacture and assembly through technical leadership and direction 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, including pFMEA. Your role will involve developing and characterizing processes that are capable, scalable, and produce high yield, as well as supporting the design of robust inspection strategies including CQA's, CTQ's, and MSA's. You will provide quality engineering support for the execution of quality assurance activities during the design transfer phases of new product development.

Responsibilities

• Foster collaborative internal and external 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 the highest levels of quality that meet NPI project goals.
• Mentor other groups and functions on areas of expertise, particularly focusing on design and process transfer.
• Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure products are free of flaws and function as designed.
• Design and install sophisticated testing equipment and perform product testing and analysis to maintain quality levels and minimize defects and failure rates.
• Analyze reports and defective products to determine trends and recommend corrective actions.
• Collaborate with supplier representatives on quality problems, ensure effective corrective actions are implemented, and contribute to supplier quality improvement programs.
• Proficient in risk management practices and tools, with high expertise in failure modes associated with production and production-related processes (PFMEA).
• Support the Risk Management File through risk management principles, evaluating process risks, risk mitigation, and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle through robust pFMEA.
• Ensure all Risk Management outputs comply with ISO14971.
• Support the design team to complete CQA/CTQ identification and inputs to dFMEA to enable process risk identification, process characterization, process capability, and robust process control.
• Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies, ensuring inspections are repeatable, efficient, and scalable.
• Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.
• Lead First Article Inspection (FAI) strategies, both internally and externally, and approve First Article Inspections.
• Optimize inspection costs through lean initiatives while maintaining the safety, integrity, and reliability of the product.
• Develop Measurement System Analysis (MSA) strategy and approve executed MSAs.
• Support the development, execution, and approval of validation strategies with the goal of highly capable processes that result in high yield and enable scalability.
• Approve protocols and reports, including data analysis.
• Influence processes towards validation versus manual verification, where possible.
• Support sterilization validation activity, as required.
• Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
• Provide expertise for NC's & CAPA's related to new products, acting as a subject matter expert and mentor in problem-solving and root-causing tools.
• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies, and tooling & fixture development.
• Support ‘process benchmarking’ by providing quality experience as a process input.
• Promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.
• Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).
• Ensure Supplier’s Quality Systems can complete process characterization and develop highly capable processes that are scalable.
• Provide Quality input to influence the proper selection of suppliers.
• Support implementation of supplier certification.
• Support Supplier Quality to establish Quality Agreements with sites and suppliers as part of NPI projects.
• Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets.
• Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
• Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.
• Support device design into production specifications.
• Lead the efficient and timely transfer of lessons learned knowledge to Quality engineering support and regional peers.
• Provide expert quality process support post-launch per DTAP agreement.
• Support the control of product through appropriate system containment to guard against product escape during pre-released builds.

Essential Skills

• Experience in ISO standards, Design Transfer, Manufacturing, Risk Management, NPI, PFMEA, Validation, Quality engineering, Medical device, Design Control, and Product Transfer.
• Bachelor of Science in Engineering or related subject.
• 3-5 years' experience in a quality or technical discipline.

Additional Skills & Qualifications

• Knowledge of CQA, CTQ, ISO14971, MSA, and PFMEA.
• This role requires the use of judgment in applying professional expertise and working independently with minimal supervision.

Work Environment

This position is onsite and offers standard benefits, including 2 weeks of PTO and 10 paid holidays. The work environment promotes collaboration and continuous improvement, focusing on maintaining high quality standards in a dynamic setting.

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 May 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $55 - $70