Quality Compliance Specialist IVD / MDD - 6 months contract

2 days left

Location
England
Salary
excellent
Posted
28 Apr 2021
Closes
19 May 2021
Ref
CR/105257
Contact
Beata Klecz
Discipline
Quality
Hours
Full Time
Contract Type
Contract
Experience Level
Management


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.
Responsibilities:

* 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

Requirements:
* 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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