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Location: Newcastle upon Tyne, Tyne and Wear Salary: Up to £35000 per annum
Sector: Manufacturing, Science Type: Permanent
Contact: Jacob Golding

Quality Assurance professional? Regulatory Affairs professional? Both!?


We have an opportunity to join a fast growing, exciting, heavily funded, new diagnostics company as a Senior QA/RA Officer.


The Quality Officer will develop, revise and implement Quality procedures and policies for the company. This will include working toward ISO 13485:2016, and in compliance with BS EN ISO 14971:2012, ensuring Regulatory compliance as the company enters commercialisation phases.


You will be responsible for planning, undertaking and recording the validation of QMS related software packages.
You will conduct internal quality system audits and external vendor assurance audits.


You will maintain QMS, Q-Pulse including monitoring and progression of CAPA and audit actions.


You will work to ensure that Quality compliance targets are met.



Skills and Experience:


Strong Quality or Regulatory experience
Experience working with ISO 13485
Experience with Medical Devices/IVD
A relevant life sciences degree
Experience of software validation
Able to work in the UK without restriction

Salary: c£35k (dependent on experience)
Permanent contract
Location: Newcastle upon Tyne

CALL NOW on 0161 839 5353 or email Jacob Golding - jacob@emp-sol.com