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
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
Principal R&D Engineer
Galway City
R&D Lifecycle Manager
Connaught
Sr Electrical Engineer
Galway
QA Engineer
Leitrim
Quality Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Director of R&D
Galway
Senior QA Associate (Investigation Lead)
Dublin
R&D Manager
Dublin
R&D Engineer
Galway
CTO
Dublin
Health & Safety Specialist
Dublin
Electronic Engineering
Dublin
Senior Director of Manufacturing and Sup
Galway
Manufacturing Technician
Galway
Senior Quality Engineer
Dublin
R&D Manager
Connaught
R&D Program Manager
Dublin
Manufacturing Technician
Clare
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Galway
Senior Microbiologist
Dublin
Quality Manager
Galway
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior R&D Engineer
Dublin
Production Manager
Dublin
Validation Engineer
Athlone
R&D Manager
Galway
Director Engineering & Supply Chain
Galway
Business Development Manager
Republic of Ireland
Product Development Engineer II
Athlone
Principal Design Assurance Engineer
Galway
NPI Engineer - Hybrid
Dublin
Senior R&D Engineer
Galway
Associate Quality Specialist
Tipperary
Injection Moulding Engineer
Athlone
Part time Opportunity-Senior QA Speciali
Dublin
R&D Technician II
Galway
Quality Engineer
Wexford
R&D Manager
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Warehouse Operator
Dublin
Biomedical Engineer
Dublin
R&D Director
Galway
Quality Assurance Team Lead
Cork
Design Assurance Manager
Galway
Validation Engineer
Carlow
Quality Engineer
Athlone
Regulatory Affairs Manager- Remote
Republic of Ireland
Senior Associate Manufacturing (Investig
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Marketing Manager
Galway
Senior Research Engineer
Galway
Senior Commissioning & Qualification
Roscommon
Continuous Improvement Coach
Limerick
Quality Technician
Dublin
Principal Quality Engineer
Galway
Industrial Designer
Galway
Quality Technician
Dublin
Senior Maintenance Technician
Roscommon
R&D Director
Galway
Senior Research Scientist
Galway
Senior QC Microbiology
Dublin
R&D Engineer
Galway
Business Development Manager (Hospitals)
Cork
Principal R&D Engineer
Galway
Dental- Manager/ Senior Manager Business
Republic of Ireland
Senior Design Assurance Engineer
Galway
Senior R&D Manager
Athlone
Senior R&D Engineer
Galway
Quality Engineer
Athlone
Manufacturing Technician
Clare
Strategic Automation Lead
Waterford
Commercial Solutions Manager (Medical De
Dublin
Software Design Assurance Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Senior Quality Engineer
Galway
Product Development Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Design Assurance Engineer
Galway
R&D Manager
Athlone
Director of Regulatory Affairs
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Senior Associate Quality Control
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Senior Quality Assurance Specialist (hyb
Dublin
Continuous Improvement Coach
Limerick
Sales/Customer Service Administrator
Clonmel
Regulatory Affairs Manager - Senior
Galway
R&D Manager
Galway
Quality Specialist
Clare
Senior QC Bioassay Associate
Dublin
Senior Design Assurance Engineer
Athlone
Senior R&D Engineer
Galway
Senior Principal R&D Engineer
Galway City
R&D Director
Galway
Engineering Business Manager
Dublin
Reg Affairs Specialist
Connaught
Technical Life Cycle & Engineering M
Galway
R&D Engineer
Clare
Senior R&D Engineer
Galway
CTO
Galway
Quality Assurance Specialist (shift)
Carlow
R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
R&D Engineer
Dublin
Senior Principal Design and Development
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Director of Quality Engineering
Limerick
Manufacturing Technician
Clare
Operations Manager
Galway
Senior QC Microbiology
Dublin
Production Operator
Meath
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Design Assurance Engineer
Galway
Principal Design Assurance Engineer
Galway
QC Specialist
Cork
Senior Operations Engineer
Galway
R&D Manager
Connaught
Quality Manager
Dublin
Injection Moulding Engineer
Athlone
R&D Engineer
Galway
Senior QC Associate - Equipment & I
Dublin
Responsible Person (RP)
Republic of Ireland
Supplier Quality Engineer
Galway
R&D Engineer
Galway
Biomedical Engineer
Dublin
Microbiology Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
R&D Manager
Galway
Product Specialist - Imaging/ Radiograph
Dublin
Project Manager
Kildare
Senior R&D Engineer
Galway
R&D Technician
Galway
Principal R&D Engineer
Galway
Quality Manager
Galway
R&D Director
Galway
Senior Quality Engineer
Dublin
Senior R&D Manager
Athlone
R&D Manager
Connaught
Product Development Manager
Galway
Operations Engineer
Galway
Product Development Technician II
Galway
Project Manager - R&D
Galway
Director of R&D
Limerick
Principal Engineer
Dublin
Design Assurance Program Manager
Galway
Quality Engineer
Galway
Senior Quality Assurance Associate
Dublin
R&D Manager
Connaught
Senior Electronic Engineer
Dublin
Quality Specialist
Tipperary
Senior Quality Engineer
Dublin
Quality Engineer
Athlone
Senior Equipment Engineer
Dublin
Inside Sales Representative (IVD Divisio
Kildare
Project Engineer
Cork
Senior Research & Development Engine
Limerick
Senior Electrical Engineer
Galway
Quality Assurance Team Lead
Cork
Senior Technology Transfer Specialist
Dublin
Senior Quality Engineer
Dublin
Director of Regulatory Affairs
Galway
Senior Maintenance Technician
Kilkenny
Calibration Technician
Republic of Ireland
Design Assurance Engineer
Galway
Documentation Specialist
Louth
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Key Account Manager - Retail UK National
South East
Laboratory Systems Specialist
Meath
Principal R&D Engineer
Galway City
QA Operations Specialist
Dublin
Project Manager
Kildare
Design Quality Engineer
Galway
Process Chemist
Limerick
Senior QC Specialist - Equipment & I
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Senior Product Development Engineer
Galway
Senior Quality Control Associate
Dublin South
Design Assurance Engineer
Galway
Quality Engineer
Galway
Senior Process Engineer - DP or DS
Dublin
Electrical Condition Monitoring Technici
Limerick
Senior R&D Engineer
Dublin
Process Engineer
Leitrim
Senior Principal R&D Engineer
Galway City
Quality Systems Manager
Dublin
QA Manager
Canada
Senior QA Specialist
Dublin
Application Software Engineer
Galway
R&D Engineer
Dublin
Quality Specialist
Clare
Senior Manufacting Engineer
Republic of Ireland
Process Engineer
Galway
Validation Engineer
Republic of Ireland
Regulatory Affairs Maanger
Galway
Senior Design Assurance Engineer
Athlone
Principal Engineer
Dublin
Quality Specialist
Dublin
R&D Manager
Galway
Quality Engineer - Supplier
Galway
Senior Production Supervisor
Galway City
Continuous Improvement Coach
Limerick
Senior Regulatory Affairs Specialist
Athlone
Senior Design Assurance Engineer
Galway
Quality Specialist
Clare
Principal R&D Engineer
Galway
Senior Research and Development Engineer
Galway
R&D Senior Program Manager
Galway
Continuous Improvement Coach
Limerick
Senior Operations Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Graduate Occupational Hygiene Consultant
Kildare
Quality Manager
Dublin
Manufacturing Technician
Clare
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

Principal Quality Engineer


Reference:JCAO0111 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Principal Engineer, Senior Quality Engineer

Principal Quality Engineer


Our client a high potential and well-funded startup company are seeking a Principal Quality Engineer to join their team. Reporting to the VP of Quality and Regulatory Affairs. The Principal Quality Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development and maintenance of the quality systems to support the organisation.


Role/Responsibilities:

  • Support the VP of Quality and Regulatory Affairs in the development and maintenance of a quality system in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
  • Manage the document control function for the group ensuring that all documents are processed in a consistent and compliant manner.
  • Represent the quality function at functional team meetings and support the teams in meeting their objectives by providing advice and completing documentation reviews in a timely manner.
  • Participate in the risk management process to ensure that all risks are captured in the risk management report and ensure that all risks are mitigated in accordance with the requirements of ISO 14971:2019.
  • Liaise with technical operations function to support the manufacture of the organisations devices ensuring that high quality product is delivered in compliance with procedures and the regulations.
  • Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
  • Ensure that all customer complaints are addressed in compliance with the appropriate regulations, ensuring that all relevant vigilance and reporting requirements are adhered to.
  • Manage and implement the CAPA system ensuring that all observations are addressed in accordance with the procedures ensuring that comprehensive root cause analysis is completed and documented appropriately comprehensively.
  • Manages Computerised System Validation in accordance with documented procedures and regulations.
  • Maintain the internal audit system ensuring that audits are completed on schedule and that all non-conformances, observations and recommendations are addressed in a timely manner.
  • Support the supplier management programme ensuring that all sub-contractors, suppliers, and external parties meet and adhere to the requirements of the quality system.
  • Prepare reports, documents, procedures, specifications, and other such technical documents as required to ensure the success of the project.
  • Support the continuous improvement of quality system processes and the business generally.
  • Complete additional tasks as designated by your supervisor to support the needs of the business.
Skills and Experience:
  • Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
  • A minimum of eight year’s experience in a quality engineering or regulatory role ideally in the medical device industry.
  • Requires excellent written, interpersonal communication and presentation skills and an ability to effectively present information to peers.
  • A self-starter who is able to see and deliver the work required to advance the company goals with a minimal amount of direction.
  • Excellent communications skills: Can understand with ease virtually everything heard or read. Can summarize information from different spoken and written sources, reconstructing arguments and accounts in a coherent presentation.
  • Has a solid grasp of team dynamics and is able to participate in teams that deliver outstanding results.
  • Holds him/herself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
  • Able to prioritize and focus on the few critical objectives amongst numerous project tasks and activities.


For further information please contact James Cassidy [email protected] or call in confidence 086 0204322