Regulatory Affairs/QA Coordinator, Medical Devices
Type: Permanent
Location: Wirral (onsite role)
Salary: £30,000 - £35,000 (depending on experience)
Additional: 25 days holiday, NEST pension scheme, 6 month probation
Our Client, a growing medical devices company are looking to appoint a RA Coordinator who will play an integral role in the continued development of the QMS & regulatory functions, working cross functionally across the QA/RA/ QC teams. This is a fantastic role for someone with experience in basic QA/RA duties (CAPA, deviations, raising non-conformances etc) to move into a full time RA role or someone with this experience to continue & develop in their career, working in an SME setting - given the autonomy to succeed in a positive environment.
The Role:
Maintenance and implementation of ISO 13485:2016 certified quality management system (QMS) including where required writing and updating SOP's and associated Forms.
Conducting internal audits of the QMS.
Overseeing external (surveillance and certification) audits of the QMS conducted by current registrar.
Documenting customer complaints.
Conducting and documenting product recalls.
Documenting and implementing corrective and preventive action /CAPA
Documenting nonconformances.
Completing management review submissions.
Completing design and development documentation.
Maintenance of medical device files.
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