- Reference: CJ46177
- Job Type: Permanent
- Location: Munster, Waterford
- Category: Medical Devices
This role works under the supervision of a Senior Quality Engineer (there are six of them in the Quality Team, reporting to the Quality Manager) Each Senior quality engineer has some quality engineers reporting to them.
This role was created specifically for support a new customer and product, a pharmaceutical product which is the first one for the Company.
More details will be given to the successful candidates in final stage of the recruitment process, due confidentiality reasons.
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 and Nypro
- 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.
For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911066 or email firstname.lastname@example.org
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