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



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

• Integration & Maintenance of the Quality Management System with all Freudenberg Medical processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Deputising for the Management Representative in their absence.
• Provision of support to all departments to ensure that products manufactured meet customer requirements
• Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
• Review and Release of batch paperwork for Product release
• Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13485. Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
• Maintenance of the Customer Complaint investigation process, MDD 93/42/EEC & MDR 2017/745 vigilance requirements assisting in product recalls & corrective/ preventive action programme
• Participation in routine Failure Investigation & process trouble-shooting
• Maintenance of plant Trending & Continuous process improvement programmes
• Participation in the Plant Corrective Action Programme
• Participation in the Internal Quality Audit Programme
• Co-ordination & maintenance of the Calibration Programme
• Co-ordination & maintenance of the Validation Programme
• Maintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenance
• Maintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standards
• Vendor Assessment liaison & Maintenance
• Ensuring that quality system & product requirements are included in the plant Training Programmes designated trainer
• Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.

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