Staff Quality Engineer, New Product Introduction (Supplier Quality)
October 3, 2021
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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.
The Staff Engineer, Quality 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.
Mentor other groups and functions on areas of expertise with particular attention to design and process transfer.
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 to enable process risk identification, process characterization, process capability and robust process control.
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 (MSA) strategy and approve executed MSAs.
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.
Influence processes towards validation versus manual verification, where possible.
Support Sterilisation validation activity, as required.
Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
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 'process bench marking' by providing quality experience as a process input.
Will promote human factor error prevention and provide expertise in the science of human factor error risk identification and mitigation.
Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP). Ensure Supplier's Quality Systems can complete process characterization and develop highly capable processes that are scalable, and meet Stryker expectations.
Provide Quality input to influence the proper selection of suppliers.
Support implementation of supplier certification.
Support Supplier Quality to establish Quality Agreements with Stryker sites and suppliers as part of NPI projects.
Represent quality assurance during the DTAP (Design Transfer Agreement Plan) process, ensuring product launches meet or exceed established metric targets including Right First Time (RFT), manufacturing loss, inspection costs per unit and product escapes, in conjunction with other targets per the DTAP.
Provide subject matter expertise in Design transfer processes and procedures, participating and interfacing in internal & external audits with regulatory representatives.
Represent NPI Quality Assurance at Design reviews and ensure integrity of the process design through robust NPI quality deliverables.
Support device design into production specifications.
Lead the efficient and timely transfer of lessons learnt knowledge to Quality engineering support, and regional peers.
Provide expert quality process support post launch per DTAP agreement.
Support the control of product, through appropriate system containment to guard against product escape during pre-released builds.
Bachelor of Science, Engineering or related subject with 4 years' experience in a quality or technical discipline or Masters of Science, Engineering or related subject with 2 years of experience in a quality or technical discipline.
Previous experience in a regulated environment within a manufacturing environment required. 2 years' experience in new product/process is a distinct advantage.
CQE or equivalent course work / experience desirable
Familiarity with advanced product quality planning framework and techniques used to develop products, a distinct advantage.
Proficient in understanding of Med Device manufacturing processes desirable.
Familiarity with ISO 13485, QSR, GDP, GMP desirable.
Lean Six Sigma training a distinct advantage.
Highly proficient in all aspects of Validation. Computer System validation a distinct advantage.
Analytical & problem solving skills, process improvement orientation, and the ability to handle multiple tasks.
Competency in Metrology including ability to interpret complex engineering drawings and understand geometrical dimensioning and tolerance.
Experience in executing complex problem-solving and process improvements techniques related to design/process/technical issues using lean six sigma tools like DMAIC.
Working knowledge/experience of risk based and statistical techniques, in particular process risk, failure mode and effect analysis (FMEA), statistical sampling plans, process capability and MSA's.
Internal Number: R457374
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK