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
Job Tools
Contact Info
Process Engineer
Cork
Cork
QA Specialist
Cork
Cork
Product Development Engineer
Galway
Galway
Electrical Engineer
Limerick
Limerick
Recruitment Consultant
Wexford
Wexford
Senior Quality Engineer
Dublin
Dublin
Medical Device Director
Republic of Ireland
Republic of Ireland
Senior Validation Engineer
Limerick
Limerick
Engineering Shift Technician
Dublin
Dublin
Associate Quality Specialist
Tipperary
Tipperary
Project Manager - R&D
Galway
Galway
Senior Quality Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
R&D Manager
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Qualified Person
Limerick
Limerick
Senior Quality Engineer
Galway
Galway
Facilities Engineer
Carlow
Carlow
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Senior Mechanical Engineer
Dublin
Dublin
Operations Specialist
Louth
Louth
QC Chemistry Analyst (Shift)
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Sourcing Specialist
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Change Control Coordinator
Carlow
Carlow
Quality Manager - NPI
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior Validation Engineer
Dublin
Dublin
Process Engineer (Shift)
Carlow
Carlow
Manufacturing Technician
Clare
Clare
EHS Systems Specialist
Carlow
Carlow
Project Manager - Suite Lead
Tipperary
Tipperary
Senior R&D Engineer
Clare
Clare
CQV Lead
Tipperary
Tipperary
Process Support Specialist
Carlow
Carlow
Director of Quality Engineering
Limerick
Limerick
QA Associate Specialist
Carlow
Carlow
Production Operator
Carlow
Carlow
Senior Process Enginer
Dublin South
Dublin South
Principal Process Equipment Engineer
Dublin South
Dublin South
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Quality Systems Manager
Dublin
Dublin
Manufacturing Engineer
Limerick
Limerick
Production Operator
Louth
Louth
Senior Engineering Manager
Limerick
Limerick
Process Support Specialist
Carlow
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
Principal R&D Engineer
Galway
Galway
Specialist Operations Engineer
Tipperary
Tipperary
Embedded Software Engineer
Dublin
Dublin
Lab Systems Specialist
Tipperary
Tipperary
Principal R&D Engineer
Dublin
Dublin
Embedded Software Engineer
Athlone
Athlone
Senior Electronics Engineer
Dublin
Dublin
Quality Manager
Dublin
Dublin
Biomedical Engineer
Dublin
Dublin
Facilities Engineer
Carlow
Carlow
Senior Technical Writer
Dublin
Dublin
R&D Manager
Galway
Galway
Senior Electrical Engineer
Galway
Galway
Planner/Scheduler
Cork
Cork
Product Development Engineer
Galway
Galway
Senior Associate Quality Operations
Limerick
Limerick
Biomedical Engineer
Dublin
Dublin
Chemical Engineer
Tipperary
Tipperary
Quality Specialist
Tipperary
Tipperary
Senior R&D Manager/Director
Dublin
Dublin
Project Engineer
Republic of Ireland
Republic of Ireland
Distribution Centre Manager
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Principal R&D Engineer
Galway
Galway
R&D Manager
Galway
Galway
Manufacturing Engineer
Wexford
Wexford
Senior Quality Engineer
Dublin
Dublin
Project Engineer
Limerick
Limerick
Senior Regulatory Affairs
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Biomedical Engineer
Dublin
Dublin
Senior Associate Quality Control
Dublin South
Dublin South
Senior R&D Project Manager
Galway
Galway
Senior R&D Engineer
Galway City
Galway City
Quality Manager
Dublin
Dublin
Senior Quality Engineer
Limerick
Limerick
Strategic Automation Lead
Waterford
Waterford
Maintenance Reliability Engineer
Tipperary
Tipperary
Maintenance Engineer
Cork
Cork
Product Development Engineer
Galway
Galway
Client Project Manager
Louth
Louth
QC Bioassay Analyst (shift)
Carlow
Carlow
Project Engineer
Clare
Clare
Automation Engineer
Cavan
Cavan
Associate Global Trade Ops
Dublin
Dublin
Project Manager
Limerick
Limerick
Engineering Business Manager
Dublin
Dublin
C&Q Lead
Tipperary
Tipperary
QC Laboratory Technician
Carlow
Carlow
Embedded Software Engineer
Dublin
Dublin
Project Engineer
Tipperary
Tipperary
Trainer
Dublin
Dublin
Senior Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Product Development Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
R&D Engineer
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Senior Validation Engineer
Limerick
Limerick
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
EHS Project Lead
Cavan
Cavan
R&D Program Manager
Dublin
Dublin
Suite Team Delivery Lead
Tipperary
Tipperary
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
Quality Validation Engineer
Limerick
Limerick
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Senior R&D Engineer
Dublin
Dublin
Senior Quality Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Biomedical Engineer
Dublin
Dublin
Quality Manager - NPI
Dublin
Dublin
Quality Engineer
Galway
Galway
Program Manager
Cork
Cork
R&D Director
Galway
Galway
Quality Technician
Carlow
Carlow
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
E&I Turnover Engineer
Carlow
Carlow
Packaging Engineer
Dublin
Dublin
Manufacturing Specialist
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior HVAC Engineer
Dublin
Dublin
Process Engineer
Limerick
Limerick
Associate Director Quality Assurance
Limerick
Limerick
Senior Electronic Engineer
Dublin
Dublin
Maintenance Engineer
Carlow
Carlow
E&I Turnover Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Senior QC 24/7 Shift
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Clean Utilities Engineer
Carlow
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Quality Engineer
Galway
Galway
Senior EHS Specialist
Louth
Louth
Project Process Engineer
Carlow
Carlow
Clinical Affairs Manager
Galway
Galway
Biomedical Engineer
Dublin
Dublin
Senior Operations Manager
Tipperary
Tipperary
Quality Systems Enginer
Dublin
Dublin
Aseptic Process Lead
Carlow
Carlow
Process Engineer
Galway
Galway
Manufacturing Engineer
Galway
Galway
Validation Engineer
Cork
Cork
Senior R&D Engineer
Clare
Clare
Recruitment Consultant
Republic of Ireland
Republic of Ireland
Maintenance CMMS Engineer
Tipperary
Tipperary
Product Development Engineer
Galway
Galway
Engineering Manager
Clare
Clare
Senior Mechanical Engineer
Dublin
Dublin
EHS Systems Specialist
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Manufacturing Shift Lead
Donegal
Donegal
Analytical Chemist
Tipperary
Tipperary
Production Operator
Carlow
Carlow
Quality Engineer
Athlone
Athlone
Digital Lab Records Specialist
Tipperary
Tipperary
Process Development Engineer
Galway
Galway
Senior QA Associate - Operations
Limerick
Limerick
Validation Engineer
Limerick
Limerick
R&D Manager
Galway
Galway
Validation Engineer
Carlow
Carlow
Quality Systems Specialist
Galway
Galway
Quality Technician
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Electrical Engineer
Cork
Cork
Senior QC Associate
Dublin
Dublin
R&D Director
Galway
Galway
Engineering Projects Lead
Carlow
Carlow
Project Manager
Louth
Louth
Quality Systems Specialist
Dublin
Dublin
Microbiology Manager
Dublin
Dublin
Senior Quality Engineer
Dublin
Dublin
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
Aseptic Process Owner Lead
Dublin
Dublin
Head of R&D
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Engineer
Galway
Galway
Process Support Specialist
Carlow
Carlow
Maintenance Planner
Carlow
Carlow
Quality Manager
Clare
Clare
Associate Quality Specialist
Tipperary
Tipperary
Principal R&D Engineer
Dublin
Dublin
R&D Senior Program Manager
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Apply for this job
Details
Senior Design Assurance Engineer
Reference: | JCAO0721 | Location: |
Galway |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
Design Assurance
Senior Design Assurance Engineer
Our client a medical device company currently seeking a Design Assurance Engineer to join their team, The Design Assurance will be working in the Quality Assurance/Regulatory Affairs departmentteam responsible for Medical Product (CE Mark and FDA 510k) Design Assurance, Design Controls, Product and Process Validation System, and Risk Management Activities.
Role/Responsibilities:
- Performs Design Assurance activities including technical reviews of design documentation and labelling, attends design reviews, coordinates and facilitates completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
- Project manager EU MDR deliverables.
- Support MDR projects as deemed necessary by the QARA Department
- Quality approver on all relevant records, tests, validations, reports, project file entries etc.
- Supports external audits including notified body and FDA audits.
- Promotes the awareness of regulatory and customer requirements throughout the organization.
- Perform standards gap analyses as required for MDR, R&D projects etc.
- QA lead for Product design transfer/validation strategy development and implementation
- Provide guidance and training for new hires and student engineers
- Support new test development and appropriate test method validation
- Lead data analysis best practice including sample planning, reporting and statistical analysis.
- Implement updates to applicable quality system requirements.
- Methodical review approach and be capable of initiating and leading change and continuous improvement.
Education/Experience:
- A degree in Engineering, Technology or Science.
- At least 5-7 years’ experience working in a regulated device or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Must have attention to detail for this Quality role.
- Training in risk management, problem solving methods, design controls, validations, usability or biocompatibility would be advantageous.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322
Project Manager Scientific Clinical Research Academic Sales and Marketing Cork City Diagnostics Cork Dublin Scientist Biopharmaceutical PhD IT Validation Engineer Chemistry Laboratory Scientist Quality Control Packaging Engineer Limerick Microbiology Sales and Marketing Medical Device Product Development Engineer Quality Engineering Pharma Sales Medical Affairs Allied Healthcare Life Science Engineering Mayo Quality Assurance Biotechnology Pharmaceutical Academic Supply Chain Connected Health Manufacturing Executive Supply Chain
Group sites:
Scientific Jobs | Engineering Jobs | Connected Health Jobs | Medical Device Jobs | Clinical Research Jobs | Biotechnology Jobs | Supply Chain Jobs | Biopharmaceutical Jobs | Quality Assurance Jobs | Contract Jobs | Chemistry Jobs | Pharmaceutical Jobs | Science Jobs | Medical Affairs Jobs
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
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