Description:
I am working with a large medical device organisation based in Waterford who are currently expanding their Quality function and will be looking to hire several Quality Engineers over the coming months.
About the role:
- Reports to Quality Function
- Monday to Friday office hours
- Dealing with Customers, Contractors, Vendors and Suppliers
- On site full time in Waterford
- Full Time Permanent position
Key Responsibilities and End Results:
- Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications.
- Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate.
- Uses scrap reduction methodologies and process capability analysis to provide a robust defect free process.
- Individual with an experienced background in sterilisation, automation, equipment/software validation.
- Individual with an experienced background in manufacturing within controlled environments.
- Individual shall support the external & internally Quality Management System auditing function (auditor trained).
- Individual shall have exposure & involvement in supporting the CAPA system.
- 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.
- Support all company safety and quality programs and initiatives.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Root cause problem solving approach in a team environment.
- Aligning customer specification to company capabilities.
- 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.
The minimum education and experience requirements:
- Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline.
- 1-5 years’ experience in a Quality Engineering role.
- Fully competent in Quality Management Standards.
- Currently be based in Ireland and willing to be onsite full time.
- Hold a valid visa currently.