Work Flexibility: Hybrid Join our Belfast team as a Quality Systems Specialist - Document Control Position Summary: The Document Control Specialist is responsible for managing, organizing, and maintaining controlled documents to ensure compliance with FDA regulations, ISO 13485, and company quality management system (QMS) requirements. This role supports cross-functional teams by ensuring accurate documentation, proper version control, and timely distribution of quality and regulatory documents within a fast-paced medical device environment. Key Areas of Responsibility: Administer the company’s document control system, including creation, revision, review, approval, distribution, and archival of controlled documents. Ensure compliance with ISO 13485, 21 CFR 820, 21 CFR Part 11, and other applicable regulatory standards for medical devices. Manage documents and document changes throughout document lifecycle within electronic documentation system, including DMR, DHF and QMS documents. Administer and maintain the electronic document management system, ensuring user access, permissions, and training records remain current. Conduct periodic reviews of role-based access to verify ongoing appropriateness and compliance. Perform document control checks to ensure documents and document changes comply with local procedures. Provide guidance to process owners, document creators, document reviewers and document approvers on the overall process and electronic management system. Collaborate with cross-functional teams to ensure timely document approval and release. Facilitate timely completion of periodic reviews. Maintain issue log for documents issued to external suppliers. Coordinate internal and external audits, including securing conference rooms, communicating with SPOs/SMEs, and coordinating front room/back room logistics. Support internal and external audits by providing documentation and ensuring records are complete, accurate, and retrievable. Perform other related duties as assigned Qualifications: Level 6 qualification 0-2 years experience Knowledge: Basic communication and project management skills. Strong interpersonal skills, written, oral communication and negotiations skills. Basic analytical and problem-solving capabilities. Demonstrated ability to work in cross-functional team environments. Basic understanding of US and International Medical Device Regulations (preferred) Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.) (Preferred) System/Computer Requirements: Basic Microsoft Office, MS Project, Adobe Acrobat Travel Percentage: 0% Stryker is one of the world’s leading medical technology companies and, together with its 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 one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.