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
Stryker is hiring a Quality Systems Specialist (Remote, Hybrid or Onsite) to support our Spine Division! The Quality Systems Specialist will support the development of the quality management system in accordance with relevant regulatory requirements for medical devices. In addition, you will oversee, support, and ensure that an effective and efficient quality management system is built and maintained, with responsibility for ensuring that all applicable quality system regulations are met to receive regulatory clearance/certification.
Work Flexibility: This role can be remote, hybrid, or onsite. 
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.
• 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.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

• Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD/MDR, and individual country requirements).
• Engage in the development of optimum future state of QMS for business needs.
• Identify improvements and inputs into the quality planning process.
• 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.
• Support GMP and GDP within Quality organization.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Support QMS training development and delivery.
• Contribute to the development, maintenance, and improvements of policies and procedures.
• Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements.
• Support notified body communication.
• Ensure QMS reflects actual activities, business needs and supports NPD requirement.
• Participate in relevant QMS Information System (IS) discussions.
• Key contributor to QMS business process(es) and understands IS system support requirements.
• Support internal and external quality system audits.
• Support IS change control assessment and approval.
• Monitoring and management of documents of external origin.
• Support of the document control system and periodic review assessments.
• Divisional Process Owner, if applicable
  
  • Coordinates input, feedback, and represents their division's needs.
  • Accountable for local process and training implementation.
  • Updates the GPO and/or PMO on divisional deliverables and progress.
  • Ensures the global initiatives in their area are communicated and understood by divisional stakeholders.
  • Serves as the voice for their division in the process area.
  • Travels to hub and spoke meetings.
  • Engages in meetings, surveys, information gathering and decisions.
  • Delivers against agreed project deadlines.
  • Communicates to leadership and stakeholders throughout levels at their division/site.

What you need:
Required:

• Bachelor's degree or 6 years equivalent experience required.

Preferred:

• Knowledge of system integration.
• Knowledge and understanding of US and International Medical Device Regulations.
• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Basic knowledge of Power BI preferred.
• Basic knowledge and understanding of Tech Street and Tarius preferred.
• Project management skills and ability to support projects of various sizes is a plus.
• Strong interpersonal skills, written, oral communication and negotiations skills.
• Demonstrated ability to work in cross-functional team environments.
• Subject matter expert for the regulatory and Stryker-business requirements of their area of ownership.
• Effective communicator and consensus-builder.

$58,700-$118,600 plus bonus eligible benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
About Stryker
Our benefits:

• 12 paid holidays annually
• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.
• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
Know someone at Stryker?
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.