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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]
Laboratory Scientist Engineering Sales and Marketing Dublin Academic Diagnostics Limerick Packaging Engineer Sales and Marketing Scientist Validation Engineer Medical Device Quality Control PhD IT Chemistry Scientific Biotechnology Academic Cork Allied Healthcare Pharma Sales Product Development Engineer Pharmaceutical Supply Chain Quality Assurance Biopharmaceutical Mayo Microbiology Cork City Connected Health Manufacturing Executive Supply Chain Life Science Medical Affairs Clinical Research Project Manager Quality Engineering
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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
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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