Quality Engineer NPD

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Quality

Quality Assurance

People Leader

Irvine, California, United States of America

The Staff Quality Engineer – Leads, plans, supervises, and coordinates quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards.

As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects. Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers.

A few of the responsibilities may involve leading a team of Quality Engineers and collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during their development cycle.

• Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management.
• Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
• Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
• Oversight, from a Quality NPD perspective, of the Non-Conformance Report (NCR) process for BWI facilities located in the U.S.
• Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA.
• Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc.). Performs statistical analysis of data generated including but not limited to:
  Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria.
• Support sterility, biocompatibility and packaging test requirements following company standard operation procedures for new products.
• Ensure that…