Quality Control Officer - Medical Devices
Hybrid working model
MUST have relevant industry experience of ISO 13485, FDA 21 CFR 820 and MDR
Supports the Quality function by maintaining compliance and providing technical input to strengthen product and service quality.
Opportunity to join a growing, innovative business with a true purpose.
The Quality Control Officer will:
- Coordinate and manage the complaint handling process for this Medical Devices company, ensuring thorough investigation, timely resolution, and accurate documentation in line with regulatory requirements.
- Conduct technical investigations into complaints, coordinating with Engineering, Production, and Service teams to establish root cause and implement corrective/preventive actions
- Contribute to continuous improvement of the Quality Management System (QMS)
- Provide technical feedback to support product improvements and risk assessments
- Maintain and update the complaints database, preparing reports for management review and highlighting trends or recurring issues.
The person:
- Strong knowledge of ISO 13485, FDA 21 CFR 820, and MDR requirements
- Minimum of 2-3 years’ experience in a Quality or Complaint Handling role within a technical or medical device environment.
- Hands-on experience with complaint handling, Corrective and Preventative Action, and root cause analysis.
- Familiarity with technical investigations involving engineering or product performance