Medical Device Quality Assurance Specialist
3 days ago
Job Overview
Kinetica is seeking an experienced quality assurance specialist to join our compliance team in West Yorkshire. As a key member of the team, you will be responsible for ensuring adherence to GMP and ISO 13485 standards.
The ideal candidate will have previous experience working within a quality role at a medical device company and a good understanding of ISO 13485.
Key Responsibilities
- Document control and change control
- NCR's, deviations, and customer complaint investigations
- QMS maintenance and management
- Root cause and CAPA
- BATCH RELEASE (£50,000 - £65,000 per annum)
- External auditing support
- Validation (sterilisation, microbiology, and environmental monitoring)
- Trend analysis and reporting
- Updating, improving, and compiling SOP's
- Internal auditing
- Quality systems training
- Leading quality improvement projects
Requirements
- Previous experience working within a quality role at a medical device company
- Experience in NCR's and CAPA
- A good understanding of ISO 13485
- Excellent attention to detail
- Excellent communication skills
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