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Stryker / Mobius Imaging Staff Quality Engineer, NPI in Shirley, Massachusetts

We are proud to be named one the World?s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards ? not to mention various social and recreational activities. Why engineering at Stryker? At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development. Need another reason to apply? Check out these 8 reasons to join Stryker?s engineering team: Who We Want Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes. What You Will Do The Staff NPI Quality Engineer will reside within the GQO Quality Assurance organization and work collaboratively with Advanced Operations and Design Assurance, with responsibility for quality assurance activities, including, but not limited to the following: General Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & 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 the NPI project goals. Mentor other groups and functions on areas of expertise with particular attention to design and process transfer. Risk Management Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA). Support the Risk Management File through risk Management Principles. Responsible for the evaluation of process risks, risk mitigation and ensures appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle (from incoming of materials/components, manufacturing, until product release) through robust pFMEA. Ensure all Risk Management outputs comply with ISO14971. Support Design team to complete CQA/CTQ identification and inputs to dFMEA. Inspection Develop and implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies. Ensure inspections are repeatable, efficient, and scalable. Lead continuous improvements of inspection methods and sampling plans, with a focus 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 safety, integrity, and reliability of the product. Develop Measurement System Analysis (M