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Details
Senior Quality Engineer
Reference: | TG - Senior QE - Leitrim | Location: |
Leitrim Longford Roscommon |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Permanent | Salary: | 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]
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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