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Job Details


Quality Systems Specialist (R476305)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Leesburg, Virginia, United States

Why RA/QA 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

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

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.


Quality Systems Specialist

Who We Want

  • Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
  • Dedicated achievers. Relentless about quality, 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.

What you will do

As a Quality Systems Specialist, you will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. You will oversee, support, and ensure that an effective and efficient quality management system is built and maintained and have responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

  • Supports 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 of QMS for business needs.
  • Identify improvements and inputs into the quality planning process.
  • Execute development and/or modification of Stryker's QMS.
  • Support Management Review and Quality Planning Review and related forums.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • 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.
  • Support notified body communication.
  • Ensure QMS reflects actual activities, business needs and supports NPD requirement.
  • Participate in relevant QMS IS discussions.
  • Basic project management understanding.
  • Key contributor to QMS business process(es) and understand IS system support requirements.
  • Support internal and external quality system audits.
  • Understands system integration.
  • Support IS change control assessment and approval.

What you need

  • Bachelor's degree in a science, engineering, business or related discipline
  • Thorough knowledge and understanding of US and International Medical Device Regulations
  • Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
  • Basic communication and project management skills
  • Strong interpersonal skills, written, oral communication and negotiations skills
  • Basic analytical and problem-solving capabilities
  • Demonstrated ability to work in cross-functional team environments
  • Experience in manufacturing environment or equivalent, preferred

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