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.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
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.
What you will do
We are a leading developer of products used to prevent hospital-acquired conditions such as ventilator-associated conditions, skin injury due to incontinence, pressure injuries, surgical site infections and healthcare worker injury across the continuum of care. From the acute care setting to the skilled nursing and long-term care setting, as well as continued care at home, we create products that make care giving easier and provide clinical outcomes. Our success is supported by a unique culture that is summed up in the phrase, "keep it personal". It's our way of reinforcing a focus and commitment to our employees and customers through integrity, honesty and passion.
As a Staff Quality Engineer, you will be a key member of the Quality Operations team ensuring the safety, efficacy, and compliance with industry practices. Working closely with Operations, Planning, Marketing, Advanced Operations, and Regulatory Affairs team members building strong relationships by fostering open communication, respect, and trust. This role is in a fast paced, high volume environment with opportunity for growth and leadership development.
Own identified internal and supplier driven non-conformances and manage the timely closure of NC's within Trackwise.
Own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
Disposition non-conforming product by leading MRB activities and issuing NC's as appropriate.
Performs PPAP activities for supplier changes.
Design and/or implement standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products.
Develop and execute standard processes, product protocols, and author technical documents including test protocols, reports and engineering studies.
Provide statistical rationale for sample size analysis of test data.
Analyze, design, and/or improve standard manufacturing procedures.
Root Cause investigations following 4D methodology and determining effective Corrective / Preventative Actions.
What you need
Bachelors Degree in Engineering or science related field
Minimum 2+ years work experience in engineering, quality, manufacturing, pharmaceuticals or regulatory
ASQ Certified Quality Engineer or similar certification preferred
Proficient understanding of Pharmaceutical / Medical Device manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, ICH Q7/Q10
Lean Six Sigma/Investigation (CAPA) training
High level knowledge/experience of risk based and statistical techniques; process risk, statistical sampling plans, process capability, and Gage R&Rs
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