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Job Details


Quality Specialist (R462592)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Salt Lake City, Utah, 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.


We're Growing Again! Come Join Our Team!

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.

Need another reason to apply? Check out these 8 reasons to join Stryker’s engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

Who we want
  • 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.

  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

  • Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive-level presentations.

What you will do
  • Environmental monitoring of cleanrooms for viable air, viable surface, and particulate in line with ISO 14644 standards.

  • Monitoring of utilities including all grades of water, and where necessary, compressed air.

  • Coordination of samples for bioburden and endotoxin testing.

  • Order consumables (media, etc.) and general stock for the day-to-day running of the laboratory.

  • Performing sampling for validations and re-qualifications as required.

  • Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending.

  • Performing sterility release review.

  • Working with operations to identify areas for risk reduction and error-proofing processes and work on implementation of these.

  • Initiating and owning of NC and CAPA

  • Developing an understanding of risk management practices and concepts, ability to become proficient in process risk.

  • Developing an understanding of optimization of inspection methods and sampling. Support First Article Inspections.

  • Developing proficiency in statistical methods and application.

  • Participating and interfacing in internal audits & external audits preparation

What you Need
  • Bachelor’s Degree in Engineering, Microbiology, or other applicable subjects. 1+ years of experience in a quality, regulatory, or microbiology discipline preferred

  • Associates Degree in any applicable subject plus 2+ years of experience in a quality, regulatory, or microbiology discipline.

  • Ability to build knowledge and understanding of US and International Medical Device Regulations and standards in the area of expertise (Microbiology)

  • Proficient in statistical techniques, data review, and analysis;

  • Effective at communicating to all levels within the organization;

  • Demonstrated team player with a customer service/stakeholder focused approach;

  • Proficient in Microsoft Office Suite

  • Experience in a Quality/Regulatory Affairs environment is desirable.


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