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
Product Development Engineer
Dublin
Head of R&D
Galway
Upstream Manufacturing Process Specialis
Cork
Technical Specialist - Manufacturing Pro
Cork
Design Assurance Program Manager
Galway
Process Engineer
Cork
Quality Management Specialist - External
Dublin South
Program Manager
Dublin
Product Development Engineer II
Athlone
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Quality Director
Galway
Principal Equipment Engineer
Dublin
Senior Director Statistics Data and Anal
Cork
Senior Design Engineer
Dublin
Regulatory Affairs Associate
Cork
Senior Regulatory Specialist
Cork
Senior R&D Engineer
Galway
R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Maintenance Technician
Kilkenny
Regulatory Affairs Associate
Cork
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Quality Assurance Engineer
Longford
Electronic Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Principal Process Development Engineer
Galway
Biostatistician
Dublin City Centre
Senior Design Engineer
Dublin
Medical Writer
Cork
Quality Engineer
Athlone
Product Development Manager
Galway
Electronic Engineering
Dublin
Senior Maintenance Technician
Roscommon
Associate R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Operations Engineer
Galway
Associate QA Specialist (Shift)
Carlow
Applications Scientist
Dublin
Product Development Engineer
Dublin
Injection Molding Engineer
North Leinster
Quality Engineer
Galway
Senior Associate QC
Dublin
QA Operations Specialist (hybrid)
Meath
Senior R&D Engineer
Galway
Senior QC Microbiology (Shift)
Dublin
Project Manager Design Assurance
Galway
Senior Mechanical Engineer
Dublin
R&D Engineer
Dublin
Senior R&D Engineer
Dublin
R&D Program Manager
Dublin
Production Operator
Meath
Reliability Engineering Consultant - Rem
Republic of Ireland
Investigation Lead
Dublin
R&D Director
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Operations Manager
Galway
R&D Director
Galway
Principal Process Equipment Engineer
Dublin South
Software Design Assurance Engineer
Dublin
Senior Process Engineer
Cork
Global Safety Senior Manager
Dublin
Operations Excellence Lead
Louth
Senior Quality Assurance Manager - Remot
Dublin
Senior Design Assurance Engineer
Clare
Product Development Technician
Galway
R&D Engineer
Galway
Quality Manager - NPI
Dublin
R&D Engineer
Clare
Senior R&D Engineer
Clare
R&D Manager
Connaught
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Principal R&D Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Recruitment Consultant
Republic of Ireland
Quality Engineer
Galway
Senior Cleaning Validation Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Dublin
Quality Assurance Specialist (Shift)
Carlow
R&D Engineer
Galway
Senior Electronics Engineer
Dublin
Production Operator
Dublin
Principal R&D Engineer
Galway
Electronic Engineer
Dublin
Project Manager - R&D
Galway
Senior Project Engineer
Cavan
Senior Cleaning Validation Engineer
Carlow
R&D Manager
Galway
R&D Technician II
Galway
Senior QC 24/7 Shift
Dublin
Production Operator
Meath
Senior Process Engineer
Cork
Senior QA Associate (Shift)
Dublin
R&D Manager
Athlone
Principal Equipment Engineer
Dublin
Senior Quality Engineer
Galway
QA Manager
Canada
Principal Engineer - R&D
Galway
Strategic Automation Lead
Waterford
E&I Turnover Engineer
Carlow
Maintenance Technician
Carlow
Quality Specialist & Deputy RP
Limerick
Project Engineer
Limerick
Sales/Customer Service Administrator
Clonmel
Quality Control Technician
Carlow
MS&T Bioprocess Engineer
Meath
Senior Associate Quality Control
Dublin
Product Development Technician II
Galway
Production Operator
Carlow
Clinical Research Associate
Cork
Senior Tech Transfer Specialist
Meath
Process Chemist
Limerick
Principal/Senior R&D Engineer Cathet
Galway
MS&T Associate Director
Dublin
Senior Analytical Scientist
Cork
Account Manager UK and Ireland
Republic of Ireland
Director of Quality Engineering
Limerick
Product Development Engineer
Galway
Injection Moulding Engineer
Athlone
CTO
Dublin
VP of Operations
Dublin
Cleaning Validation Specialist
Cork
Technology Transfer Specialist
Meath
Business Systems Director
Louth
Cleaning Validation Specialist
Cork
Quality Engineer
Galway
Project Manager
Galway
Process Engineer
Galway
Senior Manufacturing Engineer
Galway
Manufacturing Engineer
Galway
Validation Specialist - 50/50 remote
Carlow
Quality Manager
Galway
Microbiology Manager
Dublin
Senior R&D Manager
Athlone
Product Application Specialist (IVD) - I
Dublin
Project Engineer - Senior
Cavan
Manufacturing Technician
Clare
Senior Electronic Design Engineer
Dublin
Process Development Engineer
Galway
Principal R&D Engineer
Galway
Cleaning Validation Specialist
Carlow
R&D Manager
Connaught
Maintenance Reliability Engineer
Cork
Regional Program Coordinator - Global Le
Dublin
R&D Director
Galway
Quality Systems Manager
Dublin
Manufacturing Project Engineer
Sligo
Senior Validation Engineer
Carlow
Quality Engineer
Galway
Injection Molding Engineer
North Leinster
R&D Formulation Chemist
Dublin
QC Bioanalytical Analyst
Dublin North
Senior Validation Engineer
Dublin
Principal Equipment Engineer
Dublin
Regulatory Affairs Specialist
Cork
Product Development Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Technical Transfer Specialist
Cork
Principal Preclinical Scientist
Galway
R&D Engineer
Dublin
Senior Manager Clinical Quality
Cork
R&D Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
R&D Engineer
Galway
Quality Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Clinical Project Manager
Dublin
Senior QC Microbiology (24/7 Shift)
Dublin
Quality Manager
Galway
Product Development Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Senior Research and Development Engineer
Galway
Principal Equipment Engineer
Dublin
Principal Engineer
Dublin
R&D Manager
Galway
R&D Director
Galway
NPI Process Engineer
Carlow
Principal Engineer - R&D
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Project/Process Engineer - Purification
Cork
Electronic Engineer
Dublin
R&D Manager
Athlone
Senior Engineering Manager
Limerick
Senior Quality Engineer
Leitrim
R&D Manager
Galway
R&D Engineer
Galway
Maintenance CMMS Engineer
Tipperary
Quality Control Technician
Carlow
Project Manager - R&D
Galway
Principal Engineer - R&D
Galway
DeltaV Lead Automation Engineer
Tipperary
Quality Specialist
Clare
Injection Molding Engineer
North Leinster
Quality Engineer
Galway
Senior R&D Project Manager
Galway
Senior Project Engineer
Cavan
R&D Engineer
Galway
Maintenance Reliability Engineer
Tipperary
Senior R&D Manager
Athlone
R&D Engineer
Galway
Senior R&D Engineer
Clare
Manufacturing Engineer
Galway
QC Separation Analyst
Cork
Director of Regulatory Affairs
Galway
Production Operator
Meath
Manufacturing Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Quality Engineer
Galway
QC Laboratory Technician (shift)
Carlow
Associate R&D Engineer
Galway
Operations Manager
Galway
Manufacturing Engineer
Cork
Senior Quality Engineer
Dublin
Production Operator
Dublin
Utilities Engineer
Dublin
EHS Systems Specialist
Dublin
R&D Technician
Galway
R&D Senior Program Manager
Galway
QA Engineer
Leitrim
R&D Manager
Connaught
Quality Specialist
Clare
Senior Electronics Engineer
Limerick
Manufacturing Project Engineer
Mayo
Senior Quality Engineer
Dublin
QC Laboratory Technician
Carlow
Senior Human Factors Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Project Engineer
Roscommon
Quality Specialist
Tipperary
Staff R&D Engineer- Customer Focus
Dublin
R&D Manager
Galway
QA Manager
Canada
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