Quality Engineer
Leading medical devices company in Waterford City seeks a Quality Engineer to develop and implement quality plans, programs, and procedures.
- Assist in development and implementation of quality plans, programs, and procedures using quality control statistics, lean manufacturing concepts, and analyses.
- Ensure performance and product quality conform to established company, customer, and regulatory requirements.
- Review, analyze, and report on quality discrepancies related to assembly and process.
- Investigate problems and recommend disposition, modification, and corrective action for recurring or non-recurring discrepancies.
- Interface with manufacturing, engineering, customer, vendor, and subcontractor representatives to ensure requirements are met.
- Provide technical support during the NPI process to ensure compliance with FDA, QSR, and MDD standards.
- Apply quality engineering tools and techniques, including validation protocols, cGMP, PFMEAs, and DMFs.
- Use scrap reduction methodologies and process capability analysis to provide a robust defect-free process.
- Support the external and internal Quality Management System auditing function.
- Support the CAPA system and ensure ongoing compliance with GMP.
- Align customer specifications with company capabilities.
Key qualifications:
- Degree in Engineering or Science discipline.
- 3-5 years experience in a Quality Engineering role.
- Excellent leadership, communication, and organizational skills.
- Ability to motivate team members and work in a core team environment.
Benefits: