Quality Compliance Specialist IVD / MDD - 6 months contract
2 days left
- Experience Level
We have an exciting opportunity for experienced QA experts with prior track record of working with IVD product to join a busy team and support project related to approval and compliance of IVD products.
* Supporting IVD and MDD Regulatory Clinical Performance and evidence
* review and develop the required clinical performance or clinical evaluation reports for the various product lines including the clinical strategy according to the require standards.
* determine the usability of products based on the usability standards (ISO 62304) and MHRA guidelines
* Develop and or obtain stability study reports
* Suppliers risk assessment, to analyse compliance and assess risk, complaint investigation, including definition of investigation level, root cause analysis, timeliness and quality of response and trending
* Participate in the review and recall of defective product, as necessary, in order to minimise patient risk
* Facilitate development and completion of risk assessments for field issues/complaints in the field.
* Work cross-functionally to ensure the accurate application, use and updates of risk management files
* Support the process owners in the creation of guidelines and quality documents
* Assist in selection and approval of suppliers/sub-contractor
* Maintaining, updating and communicating key processes, SOPs, policies,
* Monitor internal audit non-conformances, perform trend analyses, and present findings
* Technical file preparation
* Strong experience in IVDD or MDD experience
* ISO 14971:2012
* EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices
* ISO 62366: Medical devices - Application of usability engineering to medical devices
* ISO 13485:2016 Quality Management system experience
* MEDDEV 2.7/1 revision 4 Clinical Evaluation
The role is 100% home based
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
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