Overview
Role: Senior Quality Engineer
Location: Carrick on Shannon, Leitrim
Benefits: Competitive salary, Bonus, pension and healthcare
Company:
Work with the Largest employer in Leitrim specializing in making Catheters inhouse. Cleanrooms dedicated to customers, highly 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 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.
Qualification
* 2-3 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.
Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR thomas.gallagher@lifescience.ie
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