Systems focussed Engineer required to join the Quality Assurance team in a successful and expanding plastics engineering company manufacturing medical devices and precision injection mouldings.
Experience of working within an ISO 9001 OR ISO 13485 environment preferred.
Knowledge and understanding of the regulations of ISO13485 would be highly desirable.
The successful applicant will be expected to be a key contributor to the development and maintenance of Quality Management System.
Manufacturing/Engineering background desirable but not essential.
Key Responsibilities to include but are not limited to:
- Conducting and contributing to the management of the compliance review process, identifying and implementation of system improvements.
- Authoring of critical systems documents
- Internal Auditing
- Risk Assessment and Management
- Training and assessing company employees in relation to the QMS and regulatory requirements.
- Ensure the company is informed and has up-to-date information on all applicable and necessary specifications and standards.
- Understanding of and mentoring of cGMP in the company
- Instigate improvements through the use of lean/six sigma tools.
Additional training can/will be given as/if required.
An understanding of regulatory affairs would be advantageous specifically in relation to the medical device industry and cleanrooms environments.