Have you worked in Quality Control and Regulatory Affairs? Do you have a background in Life Sciences or Medical Devices? Are you a passionate and committed individual?
REED are delighted to be assisting our well-valued life sciences client based in Newcastle on the appointment of a QA/RA Officer based in Newcastle.
This is a full-time and permanent role working 09:00-17:30 although due to the current climate with Covid, there will need to be flexibility in these hours initially. The role is offering £27,000 - 30,000 per annum DOE.
- The QA/RA Officer will work with the Quality team and will help maintain and improve the Quality Management System
- Manage individual projects and work packages
- Prepare, conduct and record internal system audits and participate in external vendor assurance audits.
- Perform regular supplier reviews.
- Maintain and administrate the electronic Quality Management System Q-Pulse.
- Promote the benefits of a quality system to all employees.
- Effectively interact with Technical, Development, Manufacturing, Sales and Marketing, Operations and Finance teams to ensure processes are performed in accordance with company procedures.
- Ensure tests and procedures are properly understood, carried out, evaluated and documented and that modifications are investigated if necessary.
- Actively participate in the asset management and control system including overseeing calibration and maintenance of assets as necessary.
- Investigate instances of non-conformance, propose possible suitable corrections, corrective and preventive actions. Review and advise on potential instances of non-conformance.
- Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files in preparation for Regulatory submissions in various markets globally with guidance from the VP QA/RA.
- QA/QC review of both internal and contractor generated documentation relating to product development, validation and verification activities as well as device manufacture records when required.
- Help to design and deliver training sessions to ensure the understanding and compliance of all employees.
- Support design review and control of change processes during product development.
- Experience of working with ISO 13485 is essential
- Good understanding of risk management for medical devices under ISO 14971
- Highly-motivated and organised
- Proven Quality Assurance experience
Our client are able to interview through the current climate with 1 stage via telephone and 1 stage face-to-face whilst adhering to social distancing measures.
Please apply ASAP to be considered!
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