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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
Manage and maintain assigned aspects of the Physio quality system related to the management of projects/programs that include field corrective action execution, CAPA execution, and others as directed by Quality management. Develop and maintain processes related to the programs to ensure compliance with all relevant laws and regulations; support the execution of these programs and processes to assure compliance to procedures and to maintain regulatory compliance.
Responsible for the Program Management of Field Actions and represents the company in agency communications
Create and champion improvement in quality systems, with specific emphasis on field action and CAPA processes across all Physio business units.
Ensure compliance with field action processes, including tracking all aspects of the filed action, monitoring, and reporting.
Establish a field action strategy, including budget and reporting requirements. Present to senior staff and obtain the necessary approvals
Responsible for the definition of field action processes, execution of plans, and training; coordinate with internal functions such as worldwide Sales and Service, Regulatory, Manufacturing, R&D, and Legal to effect planning and execution.
Partner with OUS Physio functions and partners for worldwide management of field actions.
Manage and facilitate the process for incorporating new and updated standards in the quality system; write and/or oversee the development of the relevant quality system SOPs.
Track and analyze key success indicators, adjust processes as needed.
Provide project, department, and company guidance based on current and emerging needs relating to the management of field action requirements.
Perform other related duties as assigned.
What you need
Bachelor's degree or equivalent combination of education and relevant experience
Minimum of 3 years of experience in a cGMP environment.
Minimum 7 years' experience in project/program or Field Action management
Bachelor's degree in a science or technical field
Extensive knowledge of Quality System Regulations (FDA, TUV), preferably with Class III medical devices
Ability to represent the company to the various external regulatory bodies (e.g. FDA, TUV)
Ability to drive change in the organization
Self motivated, able to accomplish multiple assignments simultaneously
Experience interacting with customers and understanding customer dynamics
Strong project management, organizational, and problem solving skills
Ability to lead, influence, negotiate, and work with all stakeholders and support staff.
Demonstrated competency in computer skills: MS Office applications, query tools, and enterprise database systems
Comfortable in a high-stress environment.
Demonstrated ability to communicate effectively over the telephone, in person, and in written form
Must be able to communicate appropriately and adequately to all management levels, including public speaking and group presentation experience
Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse
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