Quality Management Systems - Staff Specialist

Key Responsibilities

• Own and manage the Change Control process from initiation through implementation.
• Ensure changes comply with FDA, ISO 13485, and other regulatory requirements.
• Collaborate with Quality, Regulatory, R&D, and Operations teams.
• Review and improve quality system processes and documentation.
• Mentor stakeholders on change control best practices.
• Support quality system integration and process standardization.

What They're Looking For

• 5+ years of experience in a regulated industry (medical device preferred).
• Strong experience with:
• Change Control
• Quality Management Systems (QMS)
• Cross-functional collaboration
• Process improvement and compliance
• Bachelor's degree in Engineering, Science, or a related field.
• Preferred Experience:
• Medical device industry
• Quality system integration or company acquisition projects
• Technical writing and documentation
• Experience with EU MDR and global quality systems