Senior Quality Engineer, New Products Introduction (Hybrid)

at  Stryker Corporation

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: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team
We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

KNOW SOMEONE AT STRYKER?

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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role

Provide quality engineering support for the execution of quality assurance activities during design transfer phases of new product development. Will reside within the regional NPI QE team as part of 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:

• 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.
• 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 (at supplier, incoming of materials/components, manufacturing, until product release) through robust pFMEA.
• Ensure all Risk Management outputs comply with ISO14971.
• 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.
• Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
• Provide expertise for NC’s & CAPA’s related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools.
• Support Design for Manufacture and Assembly (DFMA) through process design, inspection optimization, application of state-of-the-art technologies and tooling & fixture development.
• Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.
• May support internal and external audits.
• Commit to environmental policy.
• May train others in quality assurance/GMP related topics.
• Lead quality activities during Post Launch Monitoring
• Lead investigation and on-time closure of non-conformances, corrective & preventive actions internally and at suppliers.