Sr. Quality Engineer

Sr. Quality Engineer - CAPA

This position is as a CAPA Engineer in the corrective and preventive actions (CAPA) group. Provide Quality Engineering support to CAPA system users at the St. Paul facility, to determine and document robust solutions to a wide variety of issues, ensuring delivery of the highest quality product to the customer. Key Responsibilities Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for implementing product stops documenting release criteria. Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects. Job Skills Ownership, maintenance, and improvement of CAPA group procedures and processes Work closely with NCEP and CAPA owners as a reviewer of all records to improve CAPA quality and documentation. A seasoned, experienced professional with a complete understanding and wide application of technical principles, theories, and concepts in the field. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position. Develops solutions to a wide range of difficult technical problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment in selecting innovative, practical methods to achieve problem resolution. Has a broad knowledge of various technical alternatives and an understanding of their impact on the technological environment.