Description
I have an immediate opening for a Senior Quality Systems Engineer with a leading medical device company based in Waterford. (Salary €50,000 - €60,000).The senior Quality systems Engineer is instrumental in providing support to the Quality Systems manager in setting up and maintaining the site quality management system, continuous improvement project and ensuring compliance to all quality standards and adherence to GMP requirements.
Objectives:
- To provide support to the Quality Systems Manager in the setup, maintenance and continuous improvement of the Quality System.
- To set up and maintain the complaints process.
- To manage the administration and tracking for applicable Quality Systems.
- To manage, monitor and continually improve the Internal Audit Programme
- To manage, monitor and continually improve the Supplier Quality Programme.
- To liaise with external auditors and regulatory bodies.
- Set up and maintenance of the Risk Management process
Responsibilities:
- To develop systems for the control and trending of Corrective and preventative actions.
- Set up, manage internal audits and track responses and follow ups
- Manage and support external audits
- Supplier Quality, including investigations, non-conformances, MRB, supplier audits, supplier qualifications, reporting, measuring and monitoring.
- Complaints Management, including investigations, Non conformance and CAPA management.
- Maintenance and continuous improvement of quality metrics
- Management review and quality planning
- Continuous Improvement projects
- Risk Management Process
- Site GMP training
- Change Management activities
- Global Gap analysis review
- Maintain good documentation practices for Work instructions, SOP's and Forms.
Experience Required:
- Minimum 5 years' experience in a regulated pharmaceutical/medical device environment
- Experience in Quality auditing and supplier auditing
- Experience in Database management an advantage
- Experience in using Microsoft Office products
- Experience of team working
This is an excellent permanent position in the South East, if you are interested in hearing more about this fantastic opportunity please apply directly to this advert or contact Derek Sheridan on .