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 the #5 World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
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. If you are interested in working at one of the World's Best Workplaces, apply now!
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. 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.
- Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
- User-focused creators. Engineers who design with the user in mind, developing processes and practices that help maintain compliance and support growth
- 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 Staff Quality Engineer - Central Distribution Center you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement processes. You will support quality issues and potential nonconforming material disposition processes impacting daily operations. You will manage the US CDC QMS parts regarding Value Added Services, advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
- You will work closely with CDC operations, 3rd party leadership, global CDC team and divisional business functions to ensure quality performance of services and processes.
- YOU will support identified internal and support supplier driven non-conformances and manage the timely closure of NC's within.
- You will own or support identified internal CAPAs and manage to timely root cause investigation, implementation and closure.
- You will engage in the development and improvement of the internal Labeling and Kitting (Value-Added Services) processes for existing product or services
- You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions related to continuous improvement and change management.
- You will support execution and where applicable analysis of CDC related complaints and product field actions.
- You will be an advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
- You should have a developed understanding of risk management practices and concepts and applies knowledge to CDC and supplier operations (ISO 14971).
- You will engage, perform and interface in internal and external audits providing subject matter expertise.
- You will support manufacturing transfers to the CDC, executing appropriate quality activities.
- You will need to draw on significant knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- You will need to be flexible and adaptable to demonstrate ability to multi-task and communicate effectively through project management and influence partners without authority.
What you need
- Bachelor's degree in science, engineering or related discipline OR Associates with 8+ years of experience required
- 2 + years' experience minimum in a regulated industry, Medical Device or Pharmaceuticals manufacturing environment highly preferred.
Our benefits Our total rewards offering varies by country but often includes 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.
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/