Ref No: DT17802
County Waterford, Republic of Ireland
Quality Engineer - NPI: County Waterford.
As Quality Engineer you will assist in the development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensure that performance and product quality conform to established company, customer and regulatory requirements.
• Support New Product Introduction activities relating to Quality for products, processes or technologies, and for the enhancement or extension of existing product lines.
• Provide technical support during the NPI process in ensuring that all FDA, QSR, MDR & EU GMP standards/guidelines 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, FMEA’s & support the generation of DMF’s and other applicable regulatory documents where appropriate.
• During validation phase, support the development of a compliant manufacturing process aligned to the customer's expectations, ensuring the process & product are operational ready post-validation.
• Utilize continuous improvement methodologies and process capability analysis to provide a robust defect free process.
• Support the transfer of ownership from NPI to Production phase, liasing with Programmes group and operational workcell.
• Ensure projects are prioritized in line with business needs.
• Support Quality Lead – NPI with on-going projects and new business developments.
• Support the external & internal Quality Management System auditing function.
• 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.
Interested applicants should have:
• Degree in Engineering, Science, or similar discipline.
• At least 3 to 5 years’ experience in a Quality Engineering role.
• Fully competent in Quality Management Standards.
• Excellent leadership skills, ability to motivate team members within the organisation.
• Excellent organisation, communication, computer & presentation skills.
• Excellent initiative, decision making and be able to work in a core team environment.
• Excellent time management skills.
• Solution driven with emphasis on performance and results.