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
R&D Manager
Galway
Reg Affairs Specialist
Connaught
Senior Reg Affairs Specialist - Post Mar
Galway
Analytical Scientist
Meath
Electronic Engineer
Dublin
Product Development Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Project Manager
Kildare
Engineering Support Specialist
Louth
R&D Manager
Connaught
Learning & Performance Training Asso
Dublin
Product Development Engineer
Dublin
Senior Validation Engineer
Dublin
Project Engineer
Roscommon
Quality Engineer
Galway
R&D Director
Galway
Project Manager
Kildare
Quality Engineer
Athlone
Regulatory Affairs Specialist
Cork
Electronic Engineer
Dublin
Principal R&D Engineer
Galway
Product Development Technician II
Galway
Director of Quality Engineering
Limerick
Materials Controller (Biopharma - Limeri
Limerick
Utilities Engineer
Dublin
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Engineer
Dublin
R&D Project Manager
Galway
Maintenance CMMS Engineer
Tipperary
Product Development Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Cleaning Validation Specialist
Cork
Continuous Improvement Coach
Limerick
Senior R&D Manager
Athlone
Manufacturing Technician
Galway
Senior Operations Engineer
Galway
Principal R&D Engineer
Galway
Process Chemist
Limerick
Product Development Technician II
Galway
Quality Engineer
Athlone
R&D Director
Galway
Senior R&D Engineer
Clare
Technical Marketing Manager
Wexford
Research & Develpment Manager
Galway
R&D Lifecycle Manager
Connaught
Senior Product Development Engineer
Galway
R&D Manager
Connaught
Injection Molding Engineer
North Leinster
Quality Specialist
Clare
Senior R&D Engineer - Sustaining
Galway
Product Development Engineer
Dublin
R&D Director
Galway
Senior Design Assurance Engineer
Galway
Advanced Technologies Manager
Galway
Quality Manager
Dublin
Senior R&D Engineer
Galway
Application Software Engineer
Galway
Senior Design Engineer
Dublin
R&D Manager
Galway
Manufacturing Engineer
Cork
Principal Device Engineer
Dublin
R&D Engineer
Galway
Program Manager
Dublin
R&D Manager
Dublin
Strategic Automation Lead
Waterford
Manufacturing Project Engineer
Sligo
Senior Recruitment Consultant
Republic of Ireland
Product Development Engineer
Galway
Manufacturing Technician
Clare
Senior Quality Engineer
Leitrim
CTO
Galway
Production Manager
Dublin
Director of Regulatory Affairs
Galway
Senior Regulatroy Affairs Specialsit
Galway
Injection Moulding Engineer
Leitrim
Software Design Assurance Engineer
Dublin
Lead Chemistry Analyst
Cork
Quality Assurance Senior Specialist
Louth
Manufacturing Engineer
Cork
CTO
Dublin
Reliability Engineering Consultant - Rem
Republic of Ireland
Value Stream Team Leader / Production Su
Wexford
Sr Electrical Engineer
Galway
Principal Quality Engineer
Galway
Manufacturing Technician
Galway
Quality Manager - NPI
Dublin
Maintenance Manufacturing Technician
Kilkenny
Principal Engineer
Dublin
Project Manager
Louth
Electronic Engineering
Dublin
Project Manager - R&D
Galway
Injection Molding Engineer
North Leinster
Territory Manager (Woundcare)
Cork
R&D Engineer
Galway
Senior Engineering Manager
Limerick
Documentation Specialist
Louth
Senior Associate Quality Control (Shift)
Dublin
Facilities Engineer
Carlow
R&D Manager
Athlone
Product Development Engineer II
Athlone
Principal R&D Engineer
Dublin
Product Specialist (Endoscopy)
Dublin
Process Engineer
Carlow
Manufacturing Engineer
Wexford
Quality Systems Manager
Dublin
Senior Regulatory Specialist
Cork
R&D Manager
Galway
Principal R&D Engineer
Galway
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Senior Technical Transfer Specialist
Cork
R&D Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Change Control SME
Cork
Embedded Software Engineer
Dublin
R&D Engineer
Clare
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Manager
Athlone
Electrical Condition Monitoring Technici
Limerick
Design Quality Engineer
Galway
Quality Engineer
Galway
Design Assurance Program Manager
Galway
Senior R&D Engineer
Galway
Research & Develpment Manager
Galway
Project Engineer
Limerick
Injection Molding Engineer
North Leinster
Design Assurance Engineer
Clare
QA Engineer
Leitrim
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Senior Manufacturing Engineer
Galway
National Sales Manager
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Sr R&D Manager
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Electronics Engineer
Limerick
Senior R&D Engineer-New Product Deve
Westmeath
QA Manager
Canada
Senior Regulatory Affairs Specialist
Dublin
Engineering Support Specialist
Louth
Quality Specialist
Tipperary
Senior Product Development Engineer
Galway
Engineering Business Manager
Dublin
Project Manager Design Assurance
Galway
Maintenance & Reliability Technician
Limerick
Site Microbiologist
Republic of Ireland
Project Engineer
Cork
R&D Manager
Connaught
Validation & Verification Engineer
Dublin
Injection Moulding Engineer
Athlone
Procurement Executive
Dublin
Maintenance Reliability Engineer
Cork
Senior Quality Engineer
Dublin
Senior Project Engineer
Cavan
Technical Life Cycle & Engineering M
Galway
Lead Maintenance Reliability Engineer
Westmeath
Senior R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Senior Quality Engineer
Leitrim
Principal Instrumentation & Calibrat
Limerick
Senior Quality Engineer
Dublin
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior Research & Development Engine
Limerick
Senior cGxP Laboratory Technician
Dublin
Senior R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Senior Quality Systems Engineer
Galway
Principal Design and Development Enginee
Galway
Quality Technician
Dublin
Project Manager
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Project Manager - R&D
Galway
Advanced Technologies R&D Manager
Clare
Documentation Specialist
Louth
Injection Moulding Engineer
Athlone
R&D Engineer
Galway
Senior Process Development Engineer
Galway
Senior Quality Engineer
Leitrim
Principal R&D Engineer
Galway
Quality Control Analyst (shift)
Carlow
Design Assurance Engineer
Clare
Senior Maintenance Technician
Kilkenny
R&D Senior Program Manager
Galway
Senior R&D Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Senior R&D Engineer
Galway
Principal Reliability Engineer
Galway
Director Engineering & Supply Chain
Galway
Manufacturing Technician
Clare
Process Engineer
Dublin
Regulatory Affairs Associate
Cork
Senior Regulatory Affairs Specialist
Westmeath
Process Development Engineer
Galway
Calibration Technician
Republic of Ireland
Regulatory Affairs Associate
Cork
Quality Assurance Engineer
Longford
Operational Excellence Specialist
Cork
Regulatory Specialist
Galway
Production Operator
Meath
Senior R&D Engineer
Galway
Senior Quality Assurance Specialist
Cork
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Sr R&D Manager
Galway
R&D Manager
Galway
Regulatory Associate
Cork
Manufacturing Engineer
Galway
Senior Research and Development Engineer
Galway
Mechanical Engineer
Dublin
Principal R&D Engineer
Galway
Senior QC Associate
Dublin
Customer Services Manager (Pharmaceutica
Dublin
Electronic Engineer
Dublin
Clinical Research Associate
Cork
R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
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