Company client has a fantastic opportunity for experienced Quality Engineers and Senior Quality Engineers to work for a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions.
Reporting to a Senior Quality Engineer or the Quality Manager, the successful candidate shall be responsible for the day to day QMS activities associated with the production of IVD sensors (assays) and instrumentation with emphasis on providing QA input to manufacturing support, supply chain activities, process validation, complaint investigations and/or product release. Activities such as document/process creation, review and approval of documents, batch release and internal audits are requirements of this role.
Key Roles and Responsibilities:
• Providing quality advice and support to other departments.
• QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues
• QA review of records associated with commercial and/or validation batches including the collation and archiving of all relevant batch records as part of Device History Records
Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry
Experience of working in a relevant role with a strong quality focus
Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820, MDSAP for a senior level position