Job Description
Quality Engineer - County Waterford
Job Summary:
* The Quality Engineer assists in the development and implementation of quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analysis. Ensures that performance and product quality conform to established company, customer, and regulatory requirements.
* Assists in reviewing, analyzing, and reporting on quality discrepancies related to assembly and process. Investigates problems and recommends disposition, modification, and corrective action for recurring or non-recurring discrepancies.
* Interfaces with manufacturing, engineering, customer, vendor, and subcontractor representatives to ensure requirements are met.
* Provides technical support during the NPI process to ensure all FDA, QSR, and MDD standards are achieved and maintained in respect to device classifications.
* Is fully competent in the application of quality engineering tools and techniques, with a key emphasis on validation protocols (DQ, IQ, OQ, and PQ), cGMP, PFMEA's, and supports the generation of DMF's where appropriate.
* Uses scrap reduction methodologies and process capability analysis to provide a robust defect-free process.
* Has experience in sterilisation, automation, equipment/software validation, and manufacturing within controlled environments.
* Supports the external and internal Quality Management System auditing function and is auditor trained.
* Has exposure and involvement in supporting the CAPA system.
* Closely liaises and networks with other departments to provide and drive quality inputs and initiatives into the overall operational activities of the company.
* Supports the implementation of company policies and GMP.
* Ensures ongoing compliance with GMP in all practices, recording of events, and processes.
Required Qualifications:
* Degree in Engineering/Science or similar discipline.
* At least 3-5 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 organisational, communication, computer, and presentation skills.
* Excellent initiative, decision-making, and ability to work in a core team environment.