The primary function of the Senior Quality Systems Engineer is to provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented in the lens manufacturing plant. This role will report to the Quality Systems Manager.
- Assist with the execution of Medical Device Regulation in the manufacturing plant as identified by the MDR Project team
- Implement any Plant Quality systems changes as identified by the MDR Project team
- Implement plant Change management activities for the implementation of MDR QMS Requirements
- Provide Supplier Quality support to any supplier changes / material changes that will occur due to MDR
- Support new MDR Requirements around post market surveillance
- Work closely with the plant ensuring clear communication of any new MDR requirements
- Support risk management, risk analysis and health hazard analysis associated with post market information.
- Additional requirements of the job will be specified by the Quality Systems Manager
- Third level qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Systems Engineering role.
- Experience working with an ISO13485:2016compliant quality system essential.
- Operational Excellence Training advantageous
- Self-directed and results driven team player. Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
- Strong problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
- Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization.
- Excellent organisational skills, ability to take on and drive a project
For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email email@example.com