Quality Systems Specialist - Document Control

Stryker Group; Belfast; On-site; GBP 30,000 - 40,000; Full time

Job summary

A global medical technology firm in Belfast is seeking a Quality Systems Specialist - Document Control. In this role, you will manage and maintain controlled documents ensuring compliance with FDA and ISO regulations. The ideal candidate has a Level 6 qualification and up to 2 years of experience. Responsibilities include administering the document control system and collaborating with cross-functional teams to support audits and ensure timely document approval. This role provides a hands-on opportunity in a fast-paced medical device environment.

Responsibilities

• Manage controlled documents to ensure compliance with regulations.
• Administer the document control system including revisions and approvals.
• Ensure compliance with ISO 13485 and other regulatory standards.
• Collaborate with teams for timely document approval and release.
• Facilitate internal and external audits.

Skills

Basic communication and project management skills

Strong interpersonal skills

Written and oral communication skills

Basic analytical skills

Basic problem-solving capabilities

Ability to work in cross-functional teams

Education

Level 6 qualification

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

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