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.
Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
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. Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
What you will do
As a Sr. Service Quality Engineer, you will support the Service (Repair) Depot to ensure adherence to Stryker's Quality system while minimizing customer downtime, as well as identifying opportunities for continuous improvement for existing products and providing input on Service input for new product development.
Fully support the Quality needs of the Service Depot, Field Service, failure analysis and post market analysis teams. This includes validation support and nonconformance documentation.
Conduct risk assessments on product and process nonconformance's to determine patient/user health risk; develop and document action plan to address discrepancies.
Provide oversight and approval of NC & CAPA, and mentor in problem solving and root causing activities.
Drive continuous improvement in the Quality Assurance area, including cost reduction opportunities.
Work collaboratively with operations & strategic partners, such as Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives.
Provide input for product development of serviceable product; support validation of new equipment and fixtures; create new quality inspection procedures for product acquisitions intended to be serviced.
Facilitate and lead teams of subject matter experts to generate technical documentation as appropriate.
Review and comprehend applicable Quality System Procedures, ensuring compliance to the procedures. Create or update procedures as necessary.
Prepare monthly presentations for cross-department assessment utilizing various sources of data from ERP systems, complaint databases and customer feedback.
Prioritize and manage multiple projects within process/design specifications and budget restrictions.
Responsible for initiation, management and support of Product Holds, as well as potential product escapes.
Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description for areas of expertise.
What you will need:
Bachelor's Degree in Engineering is required
2+ years' experience in engineering, quality, manufacturing, or highly regulated environment.
Experience in the medical device industry.
Knowledge of FDA, ISO and other regulations and standards preferred.
Knowledge of automation process, continuous improvement and lean manufacturing.
Knowledge of Risk Analysis, Root Cause Analysis, Statistics and practical applications preferred.
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