My Client is currently seeking a Quality Engineer to join their excellent manufacturing company in Waterford.
Responsibilities of Position:
- Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, ISO & MDD standards are achieved and maintained.
- Execution of quality engineering tools such as Change Controls, Risk Analysis (FMEA), non-conformance/deviation and CAPA management
- Supporting non-conformance management within the supply chain, internally and supporting customer complaints and queries in a timely manner
- Execution of FMEA on suppliers and internal process with the aim of understanding and reducing risk for the customer.
- Individual shall support the external & internally Quality Management System auditing function (auditor trained).
- Providing guidance to QA and non QA staff on Pharmaceutical GMP requirements
- Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
- Support the implementation of Company Policies and GMP.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
- Degree in Engineering / Science discipline.
- 2-5 years' experience in a Quality Assurance role within a Pharmaceutical company
- Fully competent in Quality Management Standards.
If you are interested in this role and hold suitable experience please contact Jennifer on 0567775550 and apply throught the link provided.