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Thomas Gallagher
Life Science

+353870612325
[email protected]
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Details

Senior Quality Engineer


Reference:TG - Senior QE - Leitrim Location: Leitrim
Longford
Roscommon
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, QA Specialist, QA Validation Specialist, QE Manufacturing Engineer, Quality Engineer, Quality Specialist, Quality Systems Engineer, Quality Systems Lead

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.

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 [email protected]