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.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
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.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
What you will do
The Senior Engineer, Change Analyst will provide technical leadership and direction in changes. Responsible for the oversight & assessment of changes to the quality management system. Will oversee and ensure that changes to quality management system processes and procedures are compliant, effective and pose no risk to the quality of the product/processes.
Will work within the QMS team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:
Execute and/or Participate in the Change Control review forums and in multi-site forums.
Lead, facilitate, and mentor teams through all stages of the change control process.
Interface between functions /departments such as Design, Quality and Operations in product, process, system, or supplier related changes.
Have responsibility for initiation of changes, assessment of the change impact and routing of all tasks, with attention to detail, for completeness, accuracy, effectivity and appropriateness
Liaise with Change Requester and SMEs during all stages of the Change Control process.
Reviews all changes for ensuring sound rationale, challenging justification, correct approval, alignment and oversight.
Monitoring completion of post release tasks to ensure completion in a timely manner.
Support and lead initiatives for continuous improvement.
Participate in cross-plant and corporate project teams in areas of change control.
Manage Change Control KPIs including reporting requirements, provide detailed updates and information in support of quality & business review forums.
Support in training needs related to the change control process
Support in the preparation, participate and follow up to Stryker Internal, Corporate and third-party compliance audits.
Qualification Knowledge Skills
An Honours Bachelor's degree (Level 8) with 3 years' experience in a quality discipline
An Honours Bachelor's degree (Level 8) with 4 years of experience in a technical discipline
Previous experience in industry desirable
Understanding of Med Device concepts desirable.
Familiarity with ISO 13485, GDP, GMP concept desirable.
Excellent communication skills and attention to detail.
Have a good understanding of engineering and quality concepts / theories.
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
Must be willing to work as part of a multi-site team, with some travel required.
Knowledge of Risk Based and statistical concepts desirable.
Problem solving and analytical skills.
Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
Accepts change openly and adopts a continuous improvement orientation to the role
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