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 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
Who we want:
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.
What you will do:
Develop quality assurance documentation to support new product development process and regulatory submissions
Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
Partner with cross-functional project teams to lead product and/or process design and development activities.
Lead risk management activities for new product development projects.
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process mitigate those issues throughout the development
Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Partner with Advanced Operations in the development of manufacturing processes for new products.
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc. Develop, review,
and approve inspection plans, routers, and product drawings for new products.
Support product design transfers to internal and/or external manufacturing facilities. Provide support and direction for other Quality Engineers.
Evaluate predicate products for relevant quality issues that may impact new product development projects.
Analyze and define critical quality attributes for product and process through risk analysis techniques.
Participate in collection of initial market feedback on new products and address early concerns.
Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
What you need:
Work Experience of 7-10 years
Educational qualification for bachelor's degree in a science, engineering or related discipline MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Prefer experience with medical device product development lifecycle, including risk management
and design/process verification and validation.
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis
(FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke. Demonstrated ability to
read and interpret CAD drawings.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
Must possess strong project management skills as well as have the ability to manage multiple
Demonstrated ability to advocate for product excellence and quality.
Demonstrated ability to effectively work cross-functionally with other departments, including advanced Operations, Product Development, Regulatory Affairs, and Marketing.
Strong interpersonal skills, written, oral communication and negotiations skills.
Strong in critical thinking and "outside the box" thinking.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
Demonstrated ability to work independently in a compliance risk situation.
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