![close](img/ie6/x.png)
Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
![]() Google Chrome |
![]() Internet Explorer |
![]() Mozilla Firefox |
![]() Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job
Details
Senior Quality Engineer
Reference: | TG - SQE - Leitrim | Location: |
Leitrim Longford Midlands Roscommon Sligo |
Qualification: | Degree | Experience: | 3-4 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
EHS Engineer, QA Validation Specialist, QE Manufacturing Engineer, Quality Engineer, Quality Specialist, Quality Systems Engineer, Quality Systems Lead, Quality Systems Specialist
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.
- 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 ORthomas.gallagher@lifescience.ie
Group sites:
Biopharmaceutical Jobs |
Biotechnology Jobs |
Chemistry Jobs |
Clinical Research Jobs |
Connected Health Jobs |
Contract Jobs |
Diagnostics Jobs |
Engineering Jobs |
Medical Affairs Jobs |
Medical Device Jobs |
Pharmaceutical Jobs |
Quality Assurance Jobs |
Science Jobs |
Scientific Jobs |
Supply Chain Jobs |
Biotechnology | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@biotechnology.ie
Copyright © 2012 Life Science Recruitment Ltd | This site uses cookies. For more information on our cookie policy visit our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS
Biotechnology | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: info@biotechnology.ie
Copyright © 2012 Life Science Recruitment Ltd | This site uses cookies. For more information on our cookie policy visit our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS
![linkedin](img/icon-linkedin2.png)
![facebook](img/icon-facebook2.png)
![blog](img/icon-wordpress2.png)
![rss](img/icon-rss2.png)
![pinterest](img/icon-pinterest2.png)
![twitter](img/icon-twitter2.png)
![](img/vmfooterlogo.png)