Quality Management System - Sr Specialist (R452026)
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.comWhy 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.
- 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 Management Systems - Sr Specialist you will work within the QMS team and be responsible for ensuing that an effective and efficient quality management system is built and maintained, as an SME on NC and CAPA process, documentation and quality process within the electronic system (TrackWise).
- You will support the Quality Management Systems compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
- Yu will contribute in developing optimum future state of QMS for business needs, aligned with Corporate, Divisional & T&E QMS.
- You will oversee and execute development, improvements and/or modification of Stryker's regional/local Quality Management Systems.
- You will develop & deliver training/compliance for QMS group.
- You will contribute to the development, maintenance and improvements of the policies and procedures.
- You will implement best in class QS practices and benchmark against industry leads and regulatory requirements.
- You will liaise and communicate with notified bodies to manage certification changes.
- You will ensure QMS reflects actual activities and business needs, and supports NPD requirements
- In a project environment you will contribute to the development and/or modification of Stryker's regional/local Quality Management Systems.
- You will proficiently take part in information systems discussions as required. Thinks about QMS from an IT perspective, including proficient contributions to SRS/URS activity.
- You will supports the Business Process Owner/QA approver in IT change control assessment and approval on behalf of the business, with understanding of change control requirements per regulatory and internal procedural requirements.
What you need
- Bachelor’s degree in engineering or related discipline required
- Minimum of 2 years’ experience in a role related to Quality Management Systems required.
- Experience working in a regulated environment required.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Strong knowledge of Quality Systems (e.g. CAPA, Audits, Management review, Quality Planning) highly preferred
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/