My client, a multinational biotechnology company in Newcastle is currently seeking the expertise of a Senior QA/RA officer to maintain and improve their quality management system by identifying potential improvements, developing, revising and implementing quality procedures and policies.
Senior QA/RA Officer Key Responsibilities:
- Compiling and maintaining technical files, medical device files and device master records in preparation for regulatory submissions
- Take an active role in product risk management processes.
- Take an active role in software development by ensuring compliance with ISO 62304 is maintained
- Design review and control of change processes during product development.
- Help train staff in Quality and Regulatory requirements, leading training sessions when necessary.
- You will administer, prepare, conduct and report internal quality system audits and external vendor assurance audits.
- Assist in the implementation of systems that facilitate productivity, improve processes and guarantee efficiency
- Maintain the company’s electronic QMS, Q-Pulse, including monitoring and progression of CAPA and audit actions
- Educated to a degree standard in a relevant scientific of engineering-based subject.
- Experience working to ISO 13485 and ISO 14971.
- Previous experience working within quality assurance
- Ability to communicate effectively with multiple departments and to represent the company in external audits.
- Experience conducting Quality and Regulatory Affairs training programmes.
This permanent vacancy for a Senior QA/RA officer is a fantastic opportunity to join a highly innovative multinational company. All candidates must be eligible to work full-time in the UK without restrictions. If you have the necessary criteria outlined above then please apply without delay.