SRG have an exciting opportunity for a highly proactive and motived individual to join an established diagnostics company as a Quality Officer based in Newcastle.
As a Quality Officer, you will identify potential improvements and efficiencies and will help to develop, revise, and implement Quality procedures and policies in aim of maintaining and improving the Quality Management System.
Your main tasks and responsibilities would include:
- You will be working with the quality team to ensure products and design and development of all products are compliant with ISO13485, ISO14971 and IEC62304
- You will be working closing with the QMS manager as well as communicating with all teams and functions within the company.
- Manage individua projects and work packages as required
- Perform regular supplier reviews
- Prepare, conduct, and record internal system audits and participate in external vendor assurance audits.
- 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.
As the ideal candidate you will have a degree in Life Science along with experience working within a Quality Management System, for a medical device company is preferred. It is beneficial that you have working experience of ISO13485 and ISO14971. The ideal candidate will be highly motivated with a good work ethic, and adaptable.
your application has been submitted