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
Responsible for quality system support for R&D projects; provide inputs to R&D designs from a quality perspective; work closely with R&D to develop verification and validation strategies for product designs and analyze the risk associated with these designs; provide statistical support and analysis; improve quality processes as they apply to new/existing product design. Works with minimum supervision for performing their duties.
Essential Duties & Responsibilities
Prepare and conduct design reviews by identifying risks associated with the product in scope and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the product development process.
Help guide R&D through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.
Establish safety, durability, craftsmanship, and reliability design input specifications based on predicate device quality reports, design reviews, risk analyses, customer research and VOC activities.
Support the definition of design verification and validation test requirements that ensure appropriate statistical rationale and objective evidence is available to support the acceptance criteria.
Provide input throughout the new product development process from a quality perspective.
Perform risk analysis and develop mitigation strategies, and partner with R&D to identify design output solutions that satisfy the product requirements.
Collaborate with Design engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.
Educate R&D on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.
Develop, create and update, as appropriate, procedures for incoming, in-process, and final inspections for new/existing product development
Conduct internal Quality system audits and be involved with CAPA projects.
Conduct training on Risk Management and QA topics.
Develop and establish usability scripts and protocols for formative and summative evaluation, as well as new product development plans and documentation relative to design validation.
Analyze and define critical quality attributes for product and process through risk analysis
Support Advanced Operations in the development of manufacturing processes for new products.
Coach and mentor other quality engineers in quality and R&D
Education & Special Trainings
B.S. Degree in science or engineering required.
M.S. om Science or engineering preferred.
Six Sigma Green or Black belt preferred.
Qualifications & Experience
3+ years relevant experience required.
Understanding of FDA, ISO 13485, and ISO 14971 and other regulations and standards preferred.
Competent with Microsoft Office (Outlook, Excel, Word, etc.)
Must possess excellent oral and written communication skills
Ability to solve problems in a high stress situation
Eagerness to assist internal and external customers
Manage projects in a timely manner
Ability to conduct and document technical investigation
Demonstrated applied knowledge ofAdvanced Quality tools such as Failure ModesEffect Analysis (FMEA), GD&T, Root CauseAnalysis, and Mistake Proofing/Poke Yoke.
Demonstrated ability to effectively work globaly and cross-functionally with other departments, includingAdvanced Operations, Product Development,Regulatory Affairs, and Marketing.
Strong in critical thinking and "outside the box" thinking.
Demonstrated ability to advocate for product excellence and quality.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) preferred.
Sedentary work: May be required to move equipment up to 50 pounds, reach, push, or pull in order to accomplish job accountabilities. Generally involved sitting most of the time.
Coordination of eye, hand and foot movement with an ability to grasp by hand and meet cognitive demands to include visual and auditory discrimination / memory, reading ability and memory retention ability.
Requires use of safety glasses in designated areas.
Closed-toe shoes must be worn on the production floor; safety shoes are recommended
Exercise discretion and independence when applying professional expertise.
Must be able to manage time, projects, stress and conflict.
Must possess strong interpersonal skills including written and oral communication.
Must be able to bring tasks through to completion with minimal supervision.
Must have the ability to prioritize work and keep detailed and confidential records.
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