Senior Quality Systems Specialist (Hybrid)

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

We are proud to be named one 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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Who we want:

• 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.
  Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
  Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• 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.

What you will do:

• Support the development of quality management system processes in accordance with relevant regulatory requirements for medical devices. Ensure effective and efficient execution of quality management system processes including, but not limited to change management and master data maintenance.

• Support QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
• Engage in the development of optimum future state QMS processes for business needs.
• Identify improvements and inputs into QMS processes.
• Execute QMS and master data changes.
• Support QMS related forums through data preparation and analysis.
• Support GMP and GDP within Quality organization.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Support QMS training development and delivery.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Ensure QMS reflects actual activities, business needs and supports NPD requirements.
• Participate in relevant QMS IS discussions.
• Demonstrate basic understanding of project management concepts.
• Serve as key contributor to QMS business process(es) and understand IS system support requirements.
• Support internal and external quality system audits.
• Demonstrate basic understanding of system integration concepts
• Support IS change control assessment and approval.

What you need-

• Bachelor’s in a science, engineering, business or related discipline.
  2+ years’ experience in Quality Systems, manufacturing or equivalent environment.
• Basic knowledge and understanding of US and International Medical Device Regulations.
• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Basic project management skills.
• Strong interpersonal skills, written, oral communication skills.
• Basic analytical and problem-solving capabilities.
• Demonstrated ability to work in cross-functional team environments.
• Computer literacy (MS Word, Excel required).
• Some travel may be required.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

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