I'm looking for...
close

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.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
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
Sean McCarthy
Life Science

+3530212339371
[email protected]
Connect with me on
Hot Science Jobs
Senior R&D Manager - Lifecycle Manag
Galway
Senior Microbiologist
Republic of Ireland
R&D Director
Galway
Injection Molding Engineer
North Leinster
Manufacturing Engineer
Galway
Senior Operations Engineer
Galway
Senior Associate QC
Dublin
Principal Process Equipment Engineer
Dublin South
Manufacturing Technician
Clare
Microbiology Manager
Dublin
Commissioning, Qualification and Valid
Carlow
Project Manager
Galway
Senior Quality Engineer
Leitrim
Quality and Regulatroy Manager
Galway
Project Manager - Capital Projects
Cork
Production Operator
Carlow
R&D Lifecycle Manager
Connaught
Senior Quality Engineer-Remote
Republic of Ireland
Validation Engineer
Cork
R&D Engineer
Galway
Medical Writer
Cork
R&D Project Manager
Galway
R&D Engineer
Dublin
Process Engineer
Cork
Product Lead
Dublin
Commissioning and Qualification Engineer
Cork
EHS Specialist
Carlow
Process Development Engineer
Galway
Senior Mechanical Engineer
Dublin
Senior R&D Manager
Athlone
Process Engineer (Shift)
Carlow
Manufacturing Technician
Clare
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
Technical Transfer Specialist
Cork
R&D Engineer
Clare
R&D Engineer
Galway
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Dublin
Project Engineer
Limerick
Warehouse Manager
Dublin
Senior Process Engineer
Dublin
Maintenance Reliability Engineer
Tipperary
Associate Director Global Regulatory Aff
Cork
Notified Body Product Assessor -Active D
Canada
Electrical Engineer
Limerick
Operational Excellence Specialist
Meath
Master Data Associate
Limerick
CQV Engineer - SIP Start Up
Denmark
R&D Manager
Connaught
Senior Research and Development Engineer
Galway
Principal Process Development Engineer
Galway
Product Development Engineer
Galway
Validation Engineer
Carlow
R&D Manager
Connaught
Injection Moulding Engineer
Leitrim
R&D Manager
Galway
R&D Senior Program Manager
Galway
Project Engineer
Roscommon
R&D Director
Galway
Commissioning and Qualification Engineer
Dublin
Senior Quality Engineer
Leitrim
Production Operator
Carlow
Cleaning Validation Specialist
Cork
Senior Associate Quality Control
Dublin
R&D Engineer
Galway
Program Manager
Cork
Clinical Monitor
Dublin
Head of R&D
Galway
Principal Engineer
Dublin
Technical Transfer Lead
Dublin
Chemical Engineer
Tipperary
Quality Specialist
Tipperary
Instrument Specialist
Tipperary
Project Engineer
Republic of Ireland
Buyer
Wexford
Project Engineer
Tipperary
Manufacturing Project Engineer
Sligo
Senior Manufacting Engineer
Republic of Ireland
E&I Turnover Engineer
Carlow
Electrical Engineer
Cork
Senior Regulatory Affairs Specialist
Athlone
Lead Maintenance Reliability Engineer
Westmeath
Senior Clinical Project Manager
Dublin
QA Engineer
Leitrim
Principal Engineer
Dublin
Process Simulation Technical Engineer
Carlow
Manufacturing Technician
Clare
Process Engineer
Galway
Senior R&D Engineer
Dublin
Biostatistician
Dublin City Centre
R&D Manager
Galway
Senior Quality Engineer
Dublin
Validation & Verification Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Design Engineer
Dublin
Senior Technical Transfer Engineer
Cork
Downstream Manufacturing Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Advanced Technologies Manager
Galway
Senior Maintenance Technician
Roscommon
Quality - Tech Transfer Specialist
Cork
Engineering Business Manager
Dublin
Maintenance Engineer
Cork
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Process Engineer
Limerick
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
Embedded Software Engineer
Dublin
Product Development Engineer
Dublin
Technical Transfer Specialist
Cork
Injection Moulding Engineer
Athlone
Senior R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Senior Recruitment Consultant
Republic of Ireland
Manufacturing Engineer
Cork
Project Enginer
Dublin South
R&D Engineer
Galway
R&D Manager
Galway
Quality Manager
Dublin
Compliance Engineer
Carlow
Senior Validation Engineer
Dublin
Senior Director Statistics Data and Anal
Cork
Validation Specialist
Cork
Senior R&D Engineer
Galway
R&D Engineer
Galway
Commisioning and Qualification Engineer
Cork
Senior Quality Engineer
Leitrim
Senior Manager Device Supplier Assurance
Dublin
QA Manager
Canada
Sales Account Manager, EMEA (Medical Dev
Dublin
Project Manager
Limerick
Project Engineer - Senior
Cavan
R&D Engineer
Galway
Technical Specialist - Analytical &
Cork
Process Validation Engineer
Cork
C&Q Lead
Tipperary
Quality Technical Services Manager - 12
Dublin
Clinical Affairs Specialist
Galway
Clean Utilities Engineer
Carlow
Production Operator
Carlow
Senior Quality Engineer
Galway
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Control Technician
Carlow
Senior Recruitment Consultant
Republic of Ireland
Upstream Manufacturing Process Specialis
Cork
QC Laboratory Technician (shift)
Carlow
R&D Engineer
Galway
CQV Lead
Tipperary
Quality Engineer
Athlone
Facilities Engineer
Carlow
Product Development Technician II
Galway
Quality Systems Manager
Dublin
Principal R&D Engineer
Dublin
NPI Process Engineer
Carlow
Principal Software Engineer
Athlone
R&D Manager
Connaught
Technology Transfer Specialist (Technica
Cork
Senior Validation Engineer
Carlow
Chief Medical Officer
Dublin
Specialist Operations Engineer
Tipperary
R&D Engineer
Dublin
Senior Microbiology Specialist - Greece
Republic of Ireland
Senior Recruitment Consultant
Dublin
Senior Human Factors Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Quality Technician
Dublin
Senior Technical Scientist - Technical T
Cork
Senior Project Manager - Process Develop
Cork
Sourcing Specialist
Tipperary
Senior R&D Manager - Lifecycle Manag
Galway
R&D Director
Galway
Maintenance Technician
Carlow
Quality Engineer
Wexford
Senior Electronic Engineer
Dublin
Product Development Engineer II
Athlone
Senior R&D Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Lead Maintenance Reliability Engineer
Westmeath
R&D Manager
Athlone
Injection Moulding Engineer
Athlone
(Senior) Manufacturing Engineers - Globa
Limerick
Project Manager - Capital Projects
Meath
Process Support Specialist
Carlow
Validation Specialist - 50/50 remote
Carlow
Product Development Engineer II
Athlone
R&D Director
Galway
Principal Heart Valves Engineer
Galway
Director of Quality Engineering
Limerick
Senior QC Associate
Dublin
Technical Transfer Engineer - Drug Subst
Louth
R&D Manager
Athlone
Senior Project Engineer - Utilities
Dublin
Maintenance Engineer
Carlow
R&D Manager
Dublin
CSV Engineer - IT Labs
Limerick
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Validation Engineer
Limerick
Senior Electronics Engineer
Dublin
Production Operator
Dublin
Senior Process Engineer
Cork
Senior R&D Manager
Athlone
Senior Equipment Design Engineer
Dublin
Validation Engineer
Limerick
R&D Technician II
Galway
Quality Assurance Engineer
Longford
Maintenance Reliability Engineer
Cork
QA Manager
Canada
R&D Engineer
Galway
Recruitment Consultant
Wexford
Chief Medical Officer
Dublin
Clinical Trial Quality Representative
Cork
Aseptic Process Lead
Carlow
Product Development Manager
Galway
Senior Electrical Engineer
Galway
Clean Utilities Engineer
Carlow
Quality Specialist
Clare
Product Development Technician II
Galway
Quality Engineer
Athlone
Clinical Research Program Manager
Galway
Recruitment Consultant
Republic of Ireland
E&I Turnover Engineer
Carlow
Production Operator
Dublin
Operations Manager
Wexford
Quality Specialist
Clare
Senior Design Quality Engineer
Dublin
R&D Program Manager
Dublin
Senior Maintenance Technician
Carlow
Senior Validation Engineer
Cork
QC External Sample and Retain Coordinato
Carlow
Senior Regulatory Affairs Specialist
Athlone
Senior Technical Transfer Specialist
Cork
Process Chemist
Limerick
Biomedical Engineer
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Quality Control NPI Senior Associate
Dublin South
Scientist (hybrid)
Meath
Senior QC 24/7 Shift
Dublin
Responsible Person (RP)
Republic of Ireland
Quality Systems Specialist
Cork
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior Design Quality Engineer


Reference:SMC37895 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Design Assurance

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.