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
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. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
As a Senior Electrical Quality Engineer, you will provide quality engineering support and direction in quality assurance, control, and preventative activities. You will focus on continuous improvement of products and processes, advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
You will work closely with operations and the business functions to ensure quality performance of product and processes.
You will work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
You will have oversight of NC/CAPA execution and act as a mentor in problem-solving and root-causing activities.
You will lead and participate in the development and improvement of the PFMEA & inspection processes for existing products.
You will review and execution of change management activities.
You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
You will support execution and analysis of complaints and product field actions.
You advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
You proficient understanding of risk management practices and concepts.
You will participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
You will assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
You will support manufacturing transfers, supplier changes, and PPAP to minimize quality issues.
You will be responsible for initiation, internal containment, and support of commercial holds for potential product escapes.
What you need
Bachelor's in electrical engineering or related discipline required
Minimum of 2+ years of experience in a regulated industry, ideally with an electrical focus
MS, CQE, or CRE preferred, Six Sigma Green or Black belt preferred.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
Understanding of US and International Medical Device Regulations highly desired
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