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 RA/QA 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/Quality Assurance 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; healthcare; insurance benefits; retirement programs; stock based 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.

Senior Specialist, Quality Management Systems (Hybrid)

Weston, FL or Mahwah, NJ

Stryker is seeking to hire a Senior Quality Management Systems Specialist, in Weston, FL or in Mahwah, NJ. Primarily responsible for the sustaining and enhancement of the change management system in accordance with relevant regulatory requirements for medical devices. Lead and ensure that an effective and efficient change management system is built and maintained. Responsibility for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

Work Flexibility: Hybrid.

This role requires reasonable proximity to our Stryker facility. You should be comfortable working 3 days onsite.

Who we want

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• 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.
• Motivated process launchers. People who bring strategic direction and drive automation of existing processes.

What you will do

• Manages the Change Management Process in onePLM.
• Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
• Contribute to the development of optimum future state of QMS for business needs.
• Identify improvements and inputs into the quality planning process.
• Oversee and execute development and/or modification of Stryker's QMS.
• Support Management Review and Quality Planning Review and related forums.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Drive GMP and GDP within Quality organization.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Develop and deliver training for QMS areas of expertise.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Liaise and communicate with notified bodies to manage certification changes.
• Ensure QMS reflects actual activities, business needs and supports NPD requirements.
• Engage in relevant QMS IS discussions.
• Basic project management understanding.
• Key contributor to QMS business process(as) and understand IS system support requirements.
• Support internal and external quality system audits.
• Understands system integration.

What you need

Required

• BS in a science, engineering, business or related discipline.
• 2+ years of experience in regulated environment and interaction with regulatory agencies required.
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Strong knowledge of the Change Management Process (Change Control)

Preferred

• Experience in Medical Devices manufacturing environment or equivalent preferred.
• Strong communication, project management and influencing skills.
• Ability to plan, organize, and implement multiple concurrent tasks.
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• Strong ability to identify opportunities for automation within existing processes.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com