Quality Systems Specialist

Belfast, Northern Ireland, United Kingdom

1/15/2025

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Support the development of the quality management system in accordance with relevant regulatory requirements for medical devices.

Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring

that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

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, 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 IS discussions.
• Basic project management understanding.
• Key contributor to QMS business process(es) and understand IS system support requirements.
• Support internal and external quality system audits.
• Understands system integration.
• Support IS change control assessment and approval.
  
  

What you will need:

• Level 8 qualification in an Engineering, Science or business related discipline
• 0-2 years experience
  
  

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 150 million patients annually.