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 Engineer
Galway
R&D Manager
Galway
Production Operator
Dublin
Clinical Trial Quality Representative
Cork
Project Engineer
Republic of Ireland
Project Manager - Capital Projects
Meath
Senior Operations Engineer
Galway
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Lead Project Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
Project Manager - R&D
Galway
Senior Quality Engineer
Leitrim
Quality Technical Services Manager - 12
Dublin
Validation & Verification Engineer
Dublin
Injection Moulding Engineer
Leitrim
Principal Quality Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Process Support Specialist
Carlow
Business Manager (Pharma Chemicals)
Westmeath
Principal Scientist Device and Product P
Dublin
Senior Regulatory Affairs Specialist
Athlone
Head of R&D
Galway
Technical Services Manager
Tipperary
Project Engineer
Tipperary
Manufacturing Project Engineer
Mayo
Senior Microbiologist
Dublin
Electrical Engineer
Cork
Quality Specialist
Clare
Associate Director Global Regulatory Aff
Cork
Senior Electronic Engineer
Dublin
Senior HVAC Engineer
Dublin
R&D Manager
Connaught
Chief Medical Officer
Dublin
Recruitment Consultant
Wexford
Process Engineer
Galway
R&D Manager
Galway
Chemical Engineer
Tipperary
Senior Validation Engineer
Cork
Quality Manager
Dublin
Cleaning Validation Specialist
Cork
Senior Engineering Manager
Limerick
Senior Quality Engineer-Remote
Republic of Ireland
Change Control Coordinator
Carlow
Senior Recruitment Consultant
Dublin
R&D Engineer
Galway
Quality Engineer
Athlone
Electronic Engineer
Dublin
Clinical Project Manager
Cork
Manufacturing Technician
Clare
Process Engineer (Shift)
Carlow
Senior Mechanical Engineer
Dublin
R&D Technician
Galway
Biomedical Engineer
Dublin
Maintenance Engineer
Carlow
QA Manager
Canada
Technical Life Cycle & Engineering M
Galway
VP of Operations
Dublin
Associate Director Clinical Development
Cork
Maintenance CMMS Engineer
Tipperary
Pharmacovigilance Manager (Remote)
Republic of Ireland
Process Chemist
Limerick
R&D Technician II
Galway
Principal R&D Engineer
Galway
Senior Validation Engineer
Carlow
Senior Technical Scientist - Technical T
Cork
Operations Manager
Wexford
Recruitment Consultant
Republic of Ireland
Validation Engineer
Athlone
Senior Product Development Engineer
Galway
Applications Scientist
Dublin
Senior Regulatory Specialist
Cork
Senior Validation Engineer
Dublin
Validation Engineer
Carlow
Sales/Customer Service Administrator
Clonmel
Quality Control Technician
Carlow
Principal R&D Engineer
Dublin
QA Compliance Specialist
Carlow
Senior Project Equipment Engineer
Dublin
Quality Systems Specialist
Galway
Maintenance CMMS Engineer
Tipperary
Senior R&D Engineer
Galway
QC Laboratory Technician
Carlow
Utilities Engineer - Black Utilities
Roscommon
Clinical Monitor
Dublin
Production Operator
Carlow
R&D Engineer
Galway
Manufacturing Technician
Clare
Senior Electronic Engineer
Dublin
Senior Associate Quality Control
Dublin
Injection Molding Engineer
North Leinster
R&D Engineer
Galway
Senior Polymer Development Engineer
Galway
Associate QA Specialist (Shift)
Carlow
Senior Human Factors Engineer
Dublin
Clean Utilities Engineer
Carlow
Commisioning and Qualification Engineer
Cork
Cleaning Validation Specialist
Cork
Staff R&D Engineer- Customer Focus
Dublin
Senior QC Associate
Dublin
Injection Moulding Engineer
Athlone
Quality Engineer
Wexford
Electronic Engineer
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Equipment Design Engineer
Dublin
R&D Engineer
Clare
R&D Manager
Galway
Principal Engineer
Dublin
Senior Process Engineer
Dublin
Validation Engineer
Cork
Senior Equipment Design Engineer
Dublin
Process Engineer (NPI)
Carlow
Senior Regulatory Affairs
Galway
Process Engineer
Cork
Senior Quality Engineer
Dublin
Manufacturing Technician
Clare
Biostatistician
Dublin City Centre
Technical Transfer Specialist
Dublin
Process Engineer
Limerick
Senior QC Associate
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Quality Specialist
Tipperary
Quality Technician
Dublin
Principal Process Equipment Engineer
Dublin South
R&D Lifecycle Manager
Connaught
Clinical Research Associate
Cork
R&D Engineer
Dublin
Senior Electronics Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Senior Quality Engineer
Galway
Quality Engineer
Galway
R&D Project Manager
Galway
C&Q Lead
Tipperary
QA Manager
Canada
Injection Moulding Engineer
Athlone
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
QA Engineer
Leitrim
QC External Sample and Retain Coordinato
Carlow
Senior Microbiologist
Republic of Ireland
Project Manager - R&D
Galway
Compliance Engineer
Carlow
Embedded Software Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Regulatory Affairs Associate
Cork
R&D Director
Galway
R&D Manager
Connaught
R&D Engineer
Dublin
Regulatory Affairs Specialist
Cork
Senior Regulatory Affairs Specialist
Dublin
Product Development Engineer II
Athlone
MS&T Bioprocess Engineer
Meath
Senior R&D Project Manager
Galway
Sr. Associate - Quality for Computer Sys
Cork
R&D Manager
Athlone
Warehouse Manager
Dublin
Product Development Manager
Galway
Validation Engineer
Limerick
R&D Director
Galway
Principal R&D Engineer
Dublin
Quality Specialist
Tipperary
Associate Director - Global Core Labelin
Cork
Senior QC 24/7 Shift
Dublin
Director of Quality Engineering
Limerick
Manufacturing Engineer
Limerick
Advanced Technologies R&D Manager
Clare
Product Development Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Senior R&D Engineer
Dublin
NPI Process Engineer
Carlow
Senior Manager Device Supplier Assurance
Dublin
R&D Manager
Galway
R&D Engineer
Galway
QC Instrumentation Engineer
Limerick
Principal Engineer
Dublin
Cleaning Validation Specialist
Carlow
Senior Supply Chain Manager
Wexford
Engineering Shift Technician
Dublin
R&D Manager
Connaught
Product Development Engineer
Dublin
Technical Specialist - Manufacturing Pro
Cork
Senior Operations Engineer
Galway
Quality Technician
Dublin
Senior R&D Engineer
Galway
Microbiology Manager
Dublin
Product Development Engineer
Galway
Maintenance Planner
Westmeath
Senior Manufacting Engineer
Republic of Ireland
Project/Process Engineer - Purification
Cork
Production Operator
Carlow
Quality - Tech Transfer Specialist
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Validation Specialist - 50/50 remote
Carlow
Senior Project Manager - Electrical
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Assurance Engineer
Longford
Lead Maintenance Reliability Engineer
Westmeath
Senior R&D Manager/Director
Dublin
National Retail Sales Manager (Ireland)
Dublin
Product Development Technician II
Galway
Quality Specialist
Clare
Senior Regulatory Specialist
Cork
Quality Engineer
Galway
Principal Device Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
R&D Manager
Connaught
QA Associate Specialist - Shift
Carlow
R&D Engineer
Galway
Product Development Engineer
Galway
Mechanical Design Engineer
Germany
Electronic Engineer
Dublin
Clinical Research Associate
Cork
Buyer
Wexford
Manufacturing Biotech Associate 24/7 Shi
Meath
R&D Manager
Athlone
Procurement Senior Specialist
Meath
Reliability Engineer
Tipperary
Remote Process Engineer - Fill Finish
Republic of Ireland
Quality Engineer
Galway
Facilities Engineer
Carlow
Senior Electrical Engineer
Galway
Manufacturing Project Engineer
Sligo
Senior QC Microbiology (24/7 Shift)
Dublin
Operational Excellence Specialist
Meath
Project Engineer
Limerick
Project Enginer
Dublin South
Suite Team Delivery Lead
Tipperary
R&D Director
Galway
Shift Technician (Injection Moulding)
Kildare
Process Support Specialist
Carlow
Quality Control NPI Senior Associate
Dublin South
CQV Lead
Tipperary
Senior R&D Engineer
Clare
Clean Utilities Engineer
Carlow
Injection Molding Engineer
North Leinster
Quality Manager
Galway
Senior Validation Engineer
Limerick
NPI Process Engineer
Carlow
Senior Recruitment Consultant
Republic of Ireland
Product Development Engineer II
Athlone
Reliability Engineering Specialist
Louth
Program Manager
Dublin
Facilities Engineer
Carlow
Advanced Technologies Manager
Galway
Project Manager
Limerick
Commissioning, Qualification and Valid
Carlow
Principal Scientist Global Regulatory Af
Cork
Senior Research and Development Engineer
Galway
E&I Turnover Engineer
Carlow
Senior Project Engineer
Cavan
R&D Manager
Dublin
Technical Transfer Lead
Dublin
Senior R&D Manager
Athlone
Senior Validation Engineer
Limerick
Manufacturing Engineer
Wexford
R&D Engineer
Galway
Quality Engineer
Athlone
Product Lead
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

Senior Quality Engineer-Remote


Reference:JCAO0603 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance, Quality Auditor, Senior Quality Engineer

Senior Quality Engineer-Remote

Our client a startup medical device company currently seeks a Senior Quality Engineer to join their team. Reporting to Quality Engineering Manager the Senior Quality Engineer is responsible for Design Assurance and Quality Engineering support for the company’s novel medical device products. This role shall support the Quality Engineering Manager for Quality Assurance and Quality Control activities related to development, manufacturing, release, and testing of medical device products in compliance applicable device and drug regulations and standards. This role is virtual position but will require travel to contract manufacturers from time to time

Role/Responsibilities

  • Provide Quality Engineering support in successful transition from development and clinical production activities to commercial manufacturing using design and manufacturability concepts, including statistical techniques.
  • Assist in the development and implementation of validation and inspection methods to analyze and assure product quality based on sound statistics.
  • Assist in quality engineering activities at contract manufacturing organizations (CMO) from receiving to final release, including but not limited to, training, validation, and continuous monitoring of product/process performance.
  • Supports Quality oversight of drug substance and drug product CMOs as well as analytical laboratories, as needed.
  • Performs disposition of batch production records, supports the conduct of internal and supplier quality audits and proactively manages issues and risks to company goals and objectives.
  • Participates in audit readiness activities for mock audits, FDA pre-approval inspection and commercial launch of the drug product.
  • Manage and conduct root cause investigations and corrective actions for nonconformances for quality issues, product design, and manufacturing & testing processes at contract manufacturing organizations.
  • Responsible for working with R&D and Operations including supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485, 21 CFR 820, 4, 210, 211, and other applicable standards and regulations pertaining to products.
  • Collaborate with Regulatory Affairs and cross functional teams to ensure appropriate execution of development and validation strategies and preparation of risk assessments as needed.
  • Review and approve method validations, change control, CAPA, deviations and investigations, in collaboration with CMOs.
  • Assist business partners to ensure that process development, manufacturing, scale up and project timelines are consistently met per corporate objectives.
  • Contribute to the successful execution of departmental and company goals.
  • Regularly update and recommend to stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
  • Assist in technology transfer to partner or contract manufacturing organizations, as applicable.
  • Support and/or lead activities related to the Post-Market Surveillance program, compiling data across departments to develop PMS plans and reports.
  • Promote and support a quality and continuous improvement culture.
  • Other miscellaneous projects/activities as assigned.
Skills/Experience
  • Bachelor’s degree in Engineering or related technical specialty.
  • Quality engineering related professional certification a plus.
  • 6+ years of experience in design/manufacturing quality engineering in the medical device industry (catheter experience preferred). Familiarity with drug-device combination products and/or drug products a plus.
  • Experience in planning and conducting product and process activities in compliance with FDA 21 CFR 820, MDD, MDR, ISO 13485 & 14971 and other applicable regulatory requirements.
  • Provided Quality oversight and guidance for cross-functional technical projects pertaining to the device product.
  • Experience with writing/editing/reviewing effective procedures and technical documents.
  • Experience with development, clinical, and commercial product release activities.
  • Experience with root cause investigations and corrective actions.
  • Experience in the oversight and management of contract manufacturing organizations.
  • Experience with Post-Market Surveillance plans and reports.


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