Sr. Quality Engineer

3 weeks ago

Irvine, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: 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. Oversight, from a Quality NPD perspective, of the Non-Conformance Report (Client) 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. Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications. Technical problem solving, failure analysis, and root cause determination. Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work. Recommend issue resolution to management for significant capability and compliance issues. Works closely with functional leadership in planning and executing project milestones. Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features. Carries out complex or Client assignments requiring the development of new or improved techniques or procedures. ssesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable. Responsible for communicating business related issues or opportunities to next management levels. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed. Requirements: Knowledge of Medical procedure and corresponding Medical Equipment Knowledge of Medical Equipment manufacturing processes Knowledge on Quality Management and its tools & techniques Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Knowledge in Statistic, Risk Management and Design control Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills.

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