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
Print this job
Send Job Spec
Share on LinkedIn
Share on Facebook
Share on Twitter
Limerick
Tipperary
Westmeath
Galway
Dublin
Galway
Tipperary
Dublin
Dublin
Carlow
Galway
Carlow
Westmeath
Dublin
Tipperary
Tipperary
Limerick
Dublin
Dublin
Tipperary
Limerick
Galway
Cavan
Leitrim
Connaught
Clare
Galway
Dublin
Limerick
Connaught
Carlow
Tipperary
Carlow
Dublin
Waterford
Dublin
Galway
Dublin
Carlow
Galway
Roscommon
Athlone
Galway
Connaught
Dublin
Athlone
Dublin South
Dublin
Dublin
Dublin
Carlow
Dublin
Athlone
Longford
Carlow
Athlone
Carlow
Dublin
Republic of Ireland
Carlow
Cork
Wexford
Carlow
Carlow
Westmeath
Dublin
Tipperary
Galway
Galway
Carlow
Carlow
Wexford
Athlone
Carlow
Carlow
Dublin
Tipperary
Galway
Athlone
Tipperary
Republic of Ireland
Galway
Dublin
Carlow
Galway
Clare
Dublin
Galway
Galway
Dublin
Galway
Galway
Limerick
Athlone
Galway
Athlone
Cavan
Tipperary
Carlow
Galway
Galway
Clare
Dublin
Waterford
Galway
Galway
Dublin
Limerick
Carlow
Dublin South
Dublin
Cork
Athlone
Republic of Ireland
Galway
Germany
Clare
Carlow
Carlow
Athlone
Dublin
Dublin
Tipperary
Connaught
Galway
Wexford
Leitrim
Dublin
Galway
Carlow
Dublin
Clare
Carlow
Dublin
Carlow
Carlow
Cork
Dublin
Dublin
Limerick
North Leinster
Dublin
Clare
Dublin South
Galway
Clare
Carlow
Limerick
Tipperary
Galway
Galway
Republic of Ireland
Limerick
Leitrim
Meath
Republic of Ireland
Carlow
Athlone
Limerick
Tipperary
Galway
Athlone
Leitrim
Dublin
Westmeath
Dublin
Dublin
Dublin
Dublin
Limerick
Westmeath
Connaught
Galway
Galway
Dublin
Limerick
Republic of Ireland
Clare
Dublin
Galway
North Leinster
Republic of Ireland
Dublin
Galway
Dublin
Clare
Dublin
Galway
Galway
Connaught
Canada
Carlow
Denmark
Westmeath
Dublin
Cork
Clare
Canada
Leitrim
Galway
Republic of Ireland
North Leinster
Galway
Dublin
Tipperary
Dublin
Dublin
Galway
Dublin South
Dublin
Republic of Ireland
Limerick
Galway
Roscommon
Wexford
Westmeath
Galway
Athlone
Galway
Republic of Ireland
Republic of Ireland
Dublin
Westmeath
Carlow
Dublin
Dublin
Cork
Louth
Galway
Dublin
Galway
Galway
Galway
Carlow
Galway
Tipperary
Limerick
Dublin
Galway
Republic of Ireland
Galway
Dublin
Galway
Dublin
Republic of Ireland
Dublin City Centre
Cork
Leitrim
Galway
Dublin South
Senior Design Quality Engineer
| Reference: | SMC37895 | Location: |
Dublin |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties
- Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle.
- Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management;
- Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents (FDA, etc)
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices,
- Supervision of and contribution to pre- and post- market risk assessments;
- Interact with other functions such as Global Design Engineering (GDE), Manufacturing, Regulatory, Product Monitoring, Clinical and Operations as necessary
- Perform internal and supplier audits
- This role may be required to lead personnel (inside and outside) within the Quality organization in support of the business need
- Supplier qualification, vendor management and performance evaluation
Education & Experience
- Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience is required or a MS with 4+ years of applicable industry experience is required.
- Experience in medical device design control including software development and product realization
- Competence in statistical tools including design of experiments and sampling methods
- Experience in design quality assurance, risk management
- Problem solving skills e.g root cause analysis and CAPA implementation
- Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems
- Understanding of human factors and user-interface design
- Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
- Lead auditor certification
- Experience in supplier management
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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
Valid XHTML - CSS
