Quality Management System Specialist

The Role 

We are seeking a detail-oriented and self-driven Quality Management System (QMS) Specialist to support and strengthen our quality and regulatory documentation processes within a regulated medical device environment. 

You will work closely with cross-functional teams to maintain controlled documentation, support compliance with applicable standards, assist with gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized, confident navigating ISO requirements, and comfortable working with a high level of precision and accountability. Experience working within ISO regulated environments, particularly ISO 13485 and or ISO 9001, is strongly preferred. 

This role is ideal for a someone who takes initiative and thrives in structured, standards-based environments. If you naturally identify gaps, ask thoughtful questions, and take ownership of documentation accuracy and process alignment, we want to hear from you!

What You’ll Do  

• Responsible for ensuring that QMS processes and documentation are conformant to applicable standards required for regulatory compliance 
• Administer and assist in the development of standards and workflows within the QMS 
• Interface with the R&D team to ensure that PDLC processes and design principles fulfill related regulatory requirements 
• Ensure that PDLC processes and documentation adhere to related standards 
• Perform gap analysis between existing processes and documentation and related standards 
• Assess compliance with standards and regulations and identify remedial actions where necessary 
• Interface with Ethical Research Boards and participating academic or health institutions during studies and trials 

Who you are  

• 3–5 years of experience working within a regulated quality environment, preferably in medical device 
• Practical experience maintaining or supporting a Quality Management System 
• Working knowledge of ISO 13485 and or ISO 9001 requirements 
• Strong documentation control and process organization skills 
• Demonstrated ability to work independently and drive tasks through to completion 
• Strong attention to detail with the ability to identify inconsistencies or gaps in documentation 
• Clear written and verbal communication skills 
• Comfortable collaborating with technical teams in a structured environment