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 in-house. The company has cleanrooms dedicated to customers, very specialized. 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.
* Deputizing 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 programs 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 program.
* Participation in routine Failure Investigation & process trouble-shooting.
* Maintenance of plant Trending & Continuous process improvement programs.
* Participation in the Plant Corrective Action Program.
* Participation in the Internal Quality Audit Program.
* Coordination & maintenance of the Calibration Program.
* Coordination & maintenance of the Validation Program.
* Maintenance of the Plant Environmental & Cleaning/Housekeeping Program, including subcontractor 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 Programs 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.
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