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Job Details


Quality Specialist (R459338)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Kalamazoo, Michigan, 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.


Who we want:

  • 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.
  • 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.

What you will do:

As a Quality Systems Specialist you will support the creation, revision, and review of quality systems documents for the Plymouth, MN site as well as support some document control activity for Instruments in MI. The QSS role is ideal for a detail oriented, self-motivated, and curious individual who can support Quality System (all applicable documentation) and Quality Assurance projects.

  • You will be responsible for ensuring compliance of all site procedures reviewed for format and content accuracy.
  • You may review and coordinate the release of new or revised Divisional procedures.
  • You will be responsible for maintaining the standards database and ensuring site and divisional procedures are compliant.
  • You will support audit functions (internal and external audits) as required.
  • You will support the coordination of any major changes to the quality system which may impact the structure, content, or its databases.
  • You will support the coordination of the NC/CAPA and Complaint processes.
  • You may conduct training on the Quality System for employees at various levels of the organization.

What you need:

  • Associates degree required (emphasis in engineering, sciences, quality or related discipline preferred).
  • 0+ years of experience
  • Quality and/or regulatory environment preferred (Medical Device, Biotech, Pharma, Aero, Auto etc).

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