Senior Quality Engineer

Location: Limerick

Job Overview: A leading provider of healthcare products is now looking to hire a Senior Quality Engineer. The primary role is to drive compliance and continuous improvement of the site Quality Management System to required Quality & Regulatory standards.

Reporting to: Quality & Operations Manager

Role Responsibilities:

• Drive compliance to key related QMS activities such as New Product Introduction, Supplier Quality, Change control, Complaints, NC & CAPA
• Monitor and drive improvements to Key Performance Indicators (KPIs)
• Management of Documentation control within QMS System
• Drive improvements to QMS documents and systems
• Coordinate Internal Audit system and Audit Team activities to required schedule
• Drive Quality requirements related to New Product Introduction, continuously assessing regulatory impact on new product releases or product updates in adherence to MDR
• Maintain appropriate product records to demonstrate compliance with applicable quality standards and regulations, ISO13485, MDD 93/42/EEC, MDR 2017/745
• Identify and implement operational improvement initiatives
• Development of appropriate trending analysis and sampling plan reviews
• Prepare for and participate in external regulatory inspections
• Other projects or duties as assigned by Manager

• Good knowledge of Quality Assurance and Regulatory Standards
• Good communication and inter-personal skills with ability to communicate clearly and concisely in both spoken and written form
• Attention to detail and accuracy to deal effectively with literature and data reviews
• Self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements
• Good technical writing skills and experience
• Good computer skills including knowledge of Microsoft®, ERP and QMS database systems
• Demonstrates behaviours in line with company core values and ethics standards

• Third level qualification in related discipline
• Minimum 4 years’ experience in a similar role
• Experience of working in a similar Quality Assurance related role in the Medical Device Industry is an advantage