Medical Device Quality Engineer | ISO 13485 & FDA QSR in Gloucester

Medical Device Quality Engineer | ISO 13485 & FDA QSR in Gloucester

Gloucester Full-Time 35000 - 45000 Β£ / year (est.) No working from home possible
Omega Resource Group

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 – 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

At Omega, we pride ourselves on being an exceptional employer, offering a supportive work culture that values collaboration and professional growth. As an Electrical Estimator in Castleford, you will enjoy competitive salaries, a generous car allowance, and comprehensive benefits including private healthcare and life insurance, all while working closely with key clients in the water sector. Join us to be part of a dynamic team where your expertise will directly contribute to impactful projects across Yorkshire.

Omega Resource Group

Contact Details:

Omega Resource Group Recruitment Team

We think you need these skills to ace Medical Device Quality Engineer | ISO 13485 & FDA QSR in Gloucester

ISO 13485
FDA 21 CFR Part 820
MDR/IVDR Compliance
Quality Management System (QMS)
CAPA Management
Non-Conformance Investigations
IQ/OQ/PQ Validation