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Staff NC/CAPA Specialist (R464431)

Equipment/Technology Specialist

Equipment and Facilities Specialist

Yearly

No

Cary, Illinois, United States

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


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.

We have been recognized, along with 24 other leading global companies, for creating globally exceptional employee experiences, high-trust relationships, and workplaces that are fair and equal for all.

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.

What you will do

Primarily responsible for the oversight of the NC/CAPA process and procedures, and ensure it is compliant, effective, and efficient in dealing with quality issues. Facilitates proactive and effective resolution of issues through expertise in problem-solving methodology.

  • Responsible for review and approval of NC and CAPAs, with attention to detail, review for completeness of actions and records, accuracy, effectivity, and timeliness along with the review and approval of CAPA changes and extension requests.

  • Develop and deliver training and coaching for new CAPA users on principles and system requirements.

  • Liaise with relevant functional groups, facilitate and mentor teams through all stages of the NC/CAPA process.

  • Lead and participate in cross-site and corporate project teams in areas of CAPA and quality system improvement.

  • Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures, and serve as CAPA super-user.

What you Need
  • BS in science, engineering, or related discipline.

  • 5+ years experience in manufacturing environment or equivalent.

  • Minimum of 2+ years experience in the area of CAPA, quality systems, engineering, or equivalent experience preferred.

  • Thorough knowledge of U.S., European, and international regulatory industry guidelines/standards and ability to interpret and apply.

  • Experience working in a compliance-risk situation with successful outcomes.

  • Highly developed problem-solving skills with demonstrated successful resolution of project-level issues.

  • Must possess strong communication, project management, and influencing skills and have the ability to manage multiple tasks simultaneously.


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