Role: Senior Quality EngineerLocation: Carrick on Shannon, LeitrimBenefits: Competitive salary, Bonus, pension and healthcareCompany: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 requirementsEnsuring 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 releaseParticipation 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 programmeParticipation in routine Failure Investigation & process trouble-shootingMaintenance of plant Trending & Continuous process improvement programmesParticipation in the Plant Corrective Action ProgrammeParticipation in the Internal Quality Audit ProgrammeCo-ordination & maintenance of the Calibration ProgrammeCo-ordination & maintenance of the Validation ProgrammeMaintenance of the Plant Environmental & Cleaning/ Housekeeping Programme, including sub-contractor maintenanceMaintenance of the Plant Laundry & Rodent Control Sub-Contractors to required standardsVendor Assessment liaison & MaintenanceEnsuring that quality system & product requirements are included in the plant Training Programmes designated trainerAdhere 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.
Qualification
2-3 years' experience as Quality/Validation Engineer in Medical Device/Pharmaceutical EnvironmentThird level qualification in Engineering / Manufacturing / Quality with emphasis on Medical Device / Biomedical.
Minimum Bachelor's degree in a Science / Engineering / Quality related disciplineAn 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 087 0612325 ******