At a Glance
- Tasks: Ensure medical devices meet quality standards and lead investigations for compliance.
- Company: Omega Resource Group, a leader in medical device quality assurance.
- Benefits: Competitive salary, day shift hours, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and continuous improvement.
- Why this job: Make a difference in healthcare by ensuring the safety and quality of medical devices.
- Qualifications: Experience in quality management systems and knowledge of ISO and FDA regulations.
The predicted salary is between 35000 - 45000 Β£ per year.
Omega Resource Group seeks a Quality Professional β Day Shift in Gloucestershire to ensure medical devices meet ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR requirements across design, manufacture and release.
You will own the QMS, lead CAPA and non-conformance investigations, drive IQ/OQ/PQ validation, and support risk management per ISO 14971 while collaborating with R&D, Manufacturing and Regulatory teams.
Medical Device Quality Engineer | ISO 13485 & FDA QSR in Gloucester employer: Omega Resource Group
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