Medical Device Quality Assurance Specialist
3 days ago
GxPeople Global is seeking a highly skilled Medical Device Quality Assurance Specialist to join their team at their headquarters in Manchester. The ideal candidate will be part of an innovative company that is at the forefront of their therapeutic area and has developed cutting-edge devices.
This full-time office-based role will involve both Quality Assurance and Quality Control activities, including supplier management, development of the quality management system, product inspection, and release.
Key Responsibilities:
- Supplier Management: SCARS, KPl's, Supplier Assessments, Supplier Agreements, supplier requalification, supplier monitoring
- External audits of suppliers
- Non-conformances: NCMR and CAPA
- Customer Complaints
- Product inspection
- Review, inspection, and authorisation of labels
- Review and approval of Device History Records (DHR) and other production documentation
- Execute Product Release
- Revision of existing QMS documentation (SOP's, WI's policies)
- Contribution to the development of new QMS procedures
Essential Qualifications:
- Familiarity with operating to ISO 13485 and compliant processes and procedures
- QA and preferably QC experience in a medical device company
- Degree qualified or quality qualification
- Minimum 2 years' experience in a relevant work setting
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