Quality Management Systems - Specialist
Job in
Cary, McHenry County, Illinois, 60013, USA
Listed on 2026-07-13
Listing for:
IntePros
Full Time
position Listed on 2026-07-13
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
Staff Specialist, Quality Management Systems
Location: Cary, IL (Hybrid – 3 days onsite, 2 days remote)
Duration: 18-month contract
Position OverviewThis role supports a major company integration following an acquisition. You'll own the Change Control process, ensure compliance with Quality Management System (QMS) requirements, and partner with cross‑functional teams to drive successful integration activities.
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.
- 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.
- Medical device industry.
- Quality system integration or company acquisition projects.
- Technical writing and documentation.
- Experience with EU MDR and global quality systems.
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