Quality Engineer - NPI

Job Title:

Quality Engineer - NPI

This role involves advocating and leading design for manufacture and assembly through technical leadership and direction in quality assurance, quality control, and preventative activities. The position supports 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. The aim is to develop and characterize processes that are capable, scalable, and produce high yield, as well as to support the design of robust inspection strategies including CQA’s, CTQ’s, and MSA’s.

Quality engineering support is provided for the execution of quality assurance activities during the design transfer phases of new product development.

• 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.

• Mentor other groups and functions on areas of expertise, with particular attention to design and process transfer.

• Develop and implement methods and procedures for process control, process improvement, testing, and inspection to ensure that the 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 and ensure that effective corrective actions are implemented.

• Support the Risk Management File through risk management principles.

• Evaluate process risks, risk mitigation, and ensure appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.

• Ensure all Risk Management outputs comply with ISO
  14971.

• Develop and implement lean inspection strategies and inspection plans.

• Lead continuous improvements of inspection methods and sampling plans, focusing on human error risk elimination.

• Lead First Article Inspection (FAI) Strategies and approve First Article Inspections.

• Support the development, execution, and approval of validation strategies.

• Provide expertise for NC’s & CAPA’s related to new products.

• Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).

• Represent quality assurance during the DTAP process, ensuring product launches meet or exceed established metric targets.

• Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.

• Proficiency in risk management practices and tools, particularly in failure modes associated with production and production-related processes (PFMEA).

• Experience in quality engineering, particularly within the medical device industry.

• Familiarity with ISO
  14971 and validation processes.

• Bachelor of Science in Engineering or a related subject with 3-5 years of experience in a quality or technical discipline.

• Ability to work independently with minimal supervision and make judgments based on practice and previous experience.

• CQA, CTQ, and MSA expertise.

• Experience in Design Transfer and Manufacturing.

• Experience in developing robust, predictive quality systems.

• Good experience in overhauling production processes, including redoing MVPs, PFMEAs, and value stream maps.

This position requires onsite work 5 days a week. Employees enjoy standard benefits, including 3 weeks of PTO and 10 paid holidays.

This is a Contract position based out of Irvine, CA.

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…