Role: Quality Engineer
Location: Carrick on Shannon, Leitrim
Benefits: Competitive salary, Bonus, pension, healthcare and hybrid working


Company:
Work with theLargest employer in Leitrim show specialise in making Catheters all inhouse. Work in a company have cleanrooms dedicated to customers, very specialised. Generally have about 100 promotions per year – Projects involved, individual plans, goal setting, leadership training.




Responsibilities

• Assist with the implementation and development of the site QMS in line with the standards to which it operates (ISO 9001, HACCP, FEMAS, BRC Storage and Distribution and GDP)
• Ensure all aspect of the QMS are implemented, documented, and maintained across the group
• Understand and work to compliance with internal procedures and policies and with the standards to which the Business operates
• Lead investigations into Quality System related issues/non-conformances to ensure a thorough root cause analysis and assignment of appropriate corrective and preventative actions
• Assure the suitability of assigned compliance actions and associated closure timelines before approval and formal entry into the site QM system.
• Maintain and control the Document Management System
• Collect and correlate data for the monitoring and measuring of the QMS, whilst tracking and trending issues and patterns to identify opportunities for improvement
• Coordinate and compile the monthly Quality Systems KPI and Metric reporting activity, both internally and externally
• Interface with other Departments on a regular basis to ensure compliance with the QMS and offer support when required
• Lead and participate in audits and their preparation in line with the Internal Audit schedule, ensuring audits are accurately documented and communicated

• Support of third-party audits and management of audit readiness throughout the business
• Post audit follow up and reporting both internally and externally on action completion and verification of effectiveness to ensure audit findings are closed out satisfactory
• Track audit results for KPI reporting

• Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelor’s degree in a Science / Engineering / Quality related discipline.
• 1+ years’ experience in a Quality role in Medical Device/Pharmaceutical Environment
• An Associate position may exist where there is limited experience and will be assigned to an experienced Engineer.