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
Dublin
Tipperary
Westmeath
Carlow
Dublin
Dublin
Dublin South
Roscommon
Westmeath
Republic of Ireland
Dublin
Dublin South
Dublin
North Leinster
Galway
Westmeath
Dublin
Carlow
Galway
Dublin
Carlow
Waterford
Galway
Galway
Dublin
Dublin
Tipperary
Limerick
Dublin
Carlow
Dublin
Carlow
Galway
Galway
Clare
Republic of Ireland
Dublin South
Carlow
Dublin
Westmeath
Athlone
Westmeath
Athlone
Carlow
Dublin
Dublin
Galway
Limerick
Limerick
Galway
Galway
Dublin
Tipperary
Galway
Dublin
Galway
Galway
Carlow
Galway
Limerick
Tipperary
Carlow
Carlow
Germany
Limerick
Carlow
Dublin
Carlow
Dublin
Clare
Dublin
Dublin
Athlone
Dublin
Galway
Westmeath
Dublin South
Dublin
Dublin
Westmeath
Dublin
Dublin
Cork
Republic of Ireland
Galway
Galway
Tipperary
Limerick
Dublin
Limerick
Carlow
Tipperary
Tipperary
Republic of Ireland
Westmeath
Dublin City Centre
Galway
Carlow
Galway
Republic of Ireland
Carlow
Tipperary
Limerick
Tipperary
Limerick
Tipperary
Dublin
Galway
Athlone
Dublin
Dublin
Wexford
Dublin
Tipperary
Louth
Dublin
Dublin
Republic of Ireland
Carlow
Leitrim
Dublin
Carlow
Carlow
Carlow
Tipperary
Dublin
Republic of Ireland
Carlow
Galway
Dublin
Canada
Wexford
Clare
Galway
Wexford
Carlow
Dublin
Galway
Galway
Carlow
Galway
Dublin
Galway
Limerick
Republic of Ireland
Republic of Ireland
Carlow
Dublin
Galway
Leitrim
Dublin
Athlone
Limerick
Galway
Dublin
Galway
Galway
Louth
Cavan
Athlone
Galway
Galway
Carlow
Carlow
Galway
Dublin
Leitrim
Dublin
Dublin
Carlow
Dublin
Republic of Ireland
Carlow
Dublin
Tipperary
Cork
Galway
Leitrim
Dublin
Galway
Tipperary
Dublin
Cork
Galway
Galway
Athlone
Republic of Ireland
Athlone
Dublin
Offaly
Dublin
Galway
Carlow
Galway
Athlone
Dublin
Cork
Leitrim
Limerick
Limerick
Carlow
Carlow
Cork
Clare
Galway
Tipperary
Tipperary
Dublin
Leitrim
Cork
Longford
Republic of Ireland
Galway
Limerick
Dublin
Cork
Limerick
Dublin
Republic of Ireland
Carlow
Tipperary
Dublin
Athlone
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