Job Description
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 Qualifications Required: Third level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical. Minimum Bachelors 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. Does this sound like your next career move? For more info forward your application or contact me on OR Skills: Quality systems Audits Benefits: Bonus, pension, healthcare and hybrid working