Job Description
Quality Engineer - County Waterford
Ref No: AM18368
County Waterford, Ireland
Job Summary:
* The Quality Engineer assists in developing and implementing quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses. Ensures that performance and product quality conform to company, customer, and regulatory requirements. Reviews, analyzes, and reports on quality discrepancies related to assembly and process. Investigates problems and recommends dispositions, modifications, and corrective actions for discrepancies. Interfaces with manufacturing, engineering, customer, vendor, and subcontractor representatives to meet requirements.
* Provides technical support during the NPI process, ensuring compliance with FDA, QSR, & MDD standards from a Healthcare/Medical device perspective.
* Applies quality engineering tools and techniques, including validation protocols (DQ, IQ, OQ, PQ), cGMP, PFMEAs, and supports DMF generation.
* Uses scrap reduction methodologies and process capability analysis to ensure a robust, defect-free process.
* Ideally has experience in sterilization, automation, equipment/software validation.
* Supports external and internal Quality Management System audits (auditor trained preferred).
* Involves supporting the CAPA system and liaising with other departments to drive quality initiatives.
* Supports the implementation of company policies, GMP, safety, and quality programs.
* Ensures ongoing GMP compliance and records all related events and processes.
* Uses root cause analysis in a team environment and aligns customer specifications with company capabilities.
Qualifications:
* Degree in Engineering, Science, or a related discipline.
* 3 to 5 years of experience in a Quality Engineering role.
* Competent in Quality Management Standards.
* Strong leadership, organizational, communication, and presentation skills.
* Proactive, decision-driven, and able to work in a team environment.
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