
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.
![]() Google Chrome |
![]() Internet Explorer |
![]() Mozilla Firefox |
![]() 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
Manufacturing Engineer
Wexford
Wexford
Engineering Projects Lead
Carlow
Carlow
Production Operator
Meath
Meath
Program Manager
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Quality Manager
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Manufacturing Engineer
Galway
Galway
Project Engineer
Cork
Cork
Process Engineer
Galway
Galway
Quality Engineer
Athlone
Athlone
Change Control Lead
Tipperary
Tipperary
Responsible Person (RP)
Republic of Ireland
Republic of Ireland
Senior R&D Engineer
Galway
Galway
Territory Sales Specialist (Life Science
Belfast City
Belfast City
Quality Systems Specialist
Tipperary
Tipperary
Production Operator
Dublin
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Republic of Ireland
Principal Engineer
Dublin
Dublin
Maintenance Technician
Kilkenny
Kilkenny
R&D Engineer
Galway
Galway
Senior Electronics Engineer
Dublin
Dublin
DeltaV Lead Automation Engineer
Tipperary
Tipperary
Quality Engineer
Galway
Galway
R&D Manager
Galway
Galway
Quality Manager - NPI
Dublin
Dublin
Senior Operations Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Mechanical Engineer
Tipperary
Tipperary
R&D Manager
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior Quality Engineer
Dublin
Dublin
Senior Project Engineer
Cavan
Cavan
Quality Technician
Dublin
Dublin
VP of Operations
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Cleaning Validation Engineer
Carlow
Carlow
Regulatory Associate
Cork
Cork
Electronic Engineer
Dublin
Dublin
Lead Manufacturing Technician
Kilkenny
Kilkenny
Quality Systems Specialist
Tipperary
Tipperary
Senior Quality Engineer
Dublin
Dublin
Senior R&D Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Head of R&D
Galway
Galway
Senior Project Engineer
Cavan
Cavan
R&D Manager
Galway
Galway
Senior Analytical Specialist
Limerick
Limerick
Lead Project Engineer
Carlow
Carlow
Project Engineer
Cork
Cork
Staff Systems Engineer
Limerick
Limerick
R&D Engineer
Dublin
Dublin
Technical Administrator
Tipperary
Tipperary
R&D Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Senior Mechanical Engineer
Dublin
Dublin
Embedded Software Engineer
Dublin
Dublin
Senior Microbiologist
Dublin
Dublin
Design Assurance Engineer
Galway
Galway
Principal Device Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Production Operator
Carlow
Carlow
Senior Quality Engineer
Galway
Galway
Senior Validation Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Injection Molding Engineer
North Leinster
North Leinster
Quality Manager - Medical Devices
Limerick City
Limerick City
Quality Engineer
Athlone
Athlone
Quality Technician
Dublin
Dublin
R&D Engineer
Galway
Galway
Principal Process Equipment Engineer
Dublin South
Dublin South
Senior R&D Engineer
Galway
Galway
EHS Systems Specialist
Dublin
Dublin
Quality Operations Manager
Dublin
Dublin
Sourcing Specialist
Tipperary
Tipperary
Senior R&D Project Manager
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Project Manager
Kildare
Kildare
Senior R&D Engineer
Clare
Clare
Product Development Engineer
Galway
Galway
Medical Secretary
Cork
Cork
R&D Engineer
Galway
Galway
Principal Software Engineer
Athlone
Athlone
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
R&D Technician II
Galway
Galway
Maintenance Technician
Carlow
Carlow
Product Development Engineer II
Athlone
Athlone
CTO
Galway
Galway
R&D Engineer
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Quality Engineer
Wexford
Wexford
Quality Engineer
Galway
Galway
EHS Specialist
Meath
Meath
Strategic Automation Lead
Waterford
Waterford
Quality Specialist & Deputy RP
Limerick
Limerick
Senior R&D Engineer
Galway
Galway
Program Manager
Galway
Galway
Senior Process Engineer
Dublin
Dublin
E&I Turnover Engineer
Carlow
Carlow
MS&T Bioprocess Engineer
Meath
Meath
Senior Regulatory Affairs Specialist
Westmeath
Westmeath
QC Bioanalytical Analyst
Dublin North
Dublin North
Graduate Manufacturing Technician
Kilkenny
Kilkenny
NPI Process Engineer
Carlow
Carlow
Senior Electrical Engineer
Galway
Galway
Applications Scientist
Dublin
Dublin
Mechanical Design Engineer
Germany
Germany
Production Operator
Dublin
Dublin
Process Engineer
Cork
Cork
Quality Engineer
Galway
Galway
Project Scheduler
Louth
Louth
R&D Manager
Connaught
Connaught
Production Operator
Carlow
Carlow
Production Manager
Dublin
Dublin
Senior QC 24/7 Shift
Dublin
Dublin
Senior Design Assurance Engineer
Athlone
Athlone
R&D Manager
Galway
Galway
Injection Moulding Engineer
Leitrim
Leitrim
Project Manager
Louth
Louth
Quality Specialist
Clare
Clare
Project Engineer
Limerick
Limerick
R&D Director
Galway
Galway
Senior Operations Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
Senior Manufacturing Manager
Dublin
Dublin
Cleaning Validation Engineer
Carlow
Carlow
Principal R&D Engineer
Galway
Galway
Principal Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Quality Engineer
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
R&D Manager
Galway
Galway
Electronic Engineering
Dublin
Dublin
R&D Project Manager
Galway
Galway
Injection Moulding Engineer
Athlone
Athlone
Injection Moulding Engineer
Athlone
Athlone
Senior Quality Engineer
Leitrim
Leitrim
R&D Engineer
Galway
Galway
Project Manager - R&D
Galway
Galway
Quality Engineer
Galway
Galway
R&D Engineer
Galway
Galway
Production Operator
Meath
Meath
Senior Electronic Engineer
Dublin
Dublin
Chief Medical Officer
Dublin
Dublin
Process Safety Specialist
Tipperary
Tipperary
Senior Quality Engineer
Leitrim
Leitrim
R&D Engineer
Galway
Galway
Quality Manager
Dublin
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Westmeath
Facilities Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Project Manager - R&D
Galway
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Westmeath
QC Systems Specialist
Dublin
Dublin
R&D Manager
Connaught
Connaught
Quality Engineer
Galway
Galway
Utilities Engineer - Black Utilities
Roscommon
Roscommon
Senior Quality Engineer-Remote
Republic of Ireland
Republic of Ireland
Clean Utilities Engineer
Carlow
Carlow
Senior Design Engineer
Dublin
Dublin
Electronic Design Engineer
Galway
Galway
Product Development Engineer
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
R&D Engineer
Galway
Galway
Product Development Manager
Galway
Galway
Senior R&D Manager
Athlone
Athlone
Quality Specialist
Tipperary
Tipperary
R&D Engineer
Galway
Galway
Electronic Engineer
Dublin
Dublin
R&D Technician II
Galway
Galway
R&D Manager
Connaught
Connaught
Senior Quality Engineer
Dublin
Dublin
CTO
Dublin
Dublin
Product Development Engineer
Dublin
Dublin
Microbiologist
Cork
Cork
Process Development Engineer
Galway
Galway
R&D Manager
Athlone
Athlone
Senior QC Associate - Cell Culture
Dublin South
Dublin South
Senior Recruitment Consultant
Republic of Ireland
Republic of Ireland
Medical Writer
Cork
Cork
Project Manager - R&D
Galway
Galway
Maintenance Reliability Engineer
Tipperary
Tipperary
Quality Control Technician
Carlow
Carlow
QA Validation Specialist
Meath
Meath
Senior Maintenance Technician
Roscommon
Roscommon
Principal R&D Engineer
Galway
Galway
R&D Engineer
Dublin
Dublin
Maintenance Technician
Kilkenny
Kilkenny
Biomedical Engineer
Dublin
Dublin
Quality Engineer
Galway
Galway
Senior Regulatory Affairs
Galway
Galway
R&D Engineer
Clare
Clare
Electronic Engineer
Dublin
Dublin
Reg Affairs Specialist
Connaught
Connaught
Biostatistician
Dublin City Centre
Dublin City Centre
R&D Manager
Galway
Galway
R&D Lifecycle Manager
Connaught
Connaught
Product Development Engineer
Dublin
Dublin
Manufacturing Technician
Clare
Clare
Senior Quality Engineer
Leitrim
Leitrim
Electronic Engineer
Dublin
Dublin
Senior Validation Engineer
Carlow
Carlow
Product Development Engineer
Galway
Galway
Senior Quality Engineer
Galway
Galway
Project Manager - Technical Transfer
Republic of Ireland
Republic of Ireland
Senior Engineering Manager
Limerick
Limerick
Project Engineer
Clare
Clare
Senior Quality Control Associate
Dublin South
Dublin South
Senior R&D Engineer
Galway
Galway
Senior R&D Engineer
Galway
Galway
Quality Specialist
Clare
Clare
Design Assurance Engineer
Galway
Galway
Biomedical Engineer
Dublin
Dublin
R&D Manager
Athlone
Athlone
Project Manager
Galway
Galway
R&D Engineer
Galway
Galway
QA Engineer
Leitrim
Leitrim
R&D Manager
Galway
Galway
Quality Control Technician
Carlow
Carlow
Manufacturing Technician
Clare
Clare
Director of Quality Engineering
Limerick
Limerick
R&D Senior Program Manager
Galway
Galway
Senior Design Engineer
Dublin
Dublin
Maintenance Technician
Kilkenny
Kilkenny
Compliance Specialist
Carlow
Carlow
Product Development Manager
Galway
Galway
Project Engineer
Cork
Cork
QA Specialist (REMOTE)
Dublin
Dublin
Validation Engineer
Athlone
Athlone
Quality Systems Specialist
Tipperary
Tipperary
Product Development Engineer
Dublin
Dublin
Injection Molding Engineer
North Leinster
North Leinster
Senior R&D Manager/Director
Dublin
Dublin
Production Operator
Meath
Meath
Principal Engineer
Dublin
Dublin
Project Engineer
Roscommon
Roscommon
NPI Process Engineer
Carlow
Carlow
Principal Quality Engineer
Galway
Galway
R&D Engineer
Galway
Galway
R&D Technician
Galway
Galway
Principal R&D Engineer
Dublin
Dublin
Medical Secretary
Cork
Cork
R&D Manager
Connaught
Connaught
Senior Quality Engineer
Leitrim
Leitrim
R&D Engineer
Galway
Galway
Utilities Engineer
Dublin
Dublin
R&D Director
Galway
Galway
Senior Electronics Engineer
Limerick
Limerick
Product Development Engineer II
Athlone
Athlone
Senior Manufacting Engineer
Republic of Ireland
Republic of Ireland
MS&T Associate Director
Dublin
Dublin
Engineering Business Manager
Dublin
Dublin
Production Operator
Carlow
Carlow
Manufacturing Engineer
Galway
Galway
Senior Electronic Engineer
Dublin
Dublin
Senior Associate QC
Dublin
Dublin
Senior R&D Engineer
Clare
Clare
Senior R&D Engineer
Clare
Clare
Technical Transfer Specialist - Remote
Republic of Ireland
Republic of Ireland
Injection Molding Engineer
North Leinster
North Leinster
Microbiology Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
Maintenance CMMS Engineer
Tipperary
Tipperary
Senior R&D Manager
Athlone
Athlone
Senior Validation Engineer
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Senior Quality Engineer
Dublin
Dublin
Electronic Engineer
Dublin
Dublin
Process Support Specialist
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Reliability Engineering Consultant - Rem
Republic of Ireland
Republic of Ireland
Manufacturing Technician
Clare
Clare
QA Manager
Canada
Canada
R&D Director
Galway
Galway
Scientist (hybrid)
Meath
Meath
Quality Engineer
Galway
Galway
Senior Procurement Associate
Limerick
Limerick
Project Manager
Kildare
Kildare
Account Manager UK and Ireland
Republic of Ireland
Republic of Ireland
QA Specialist (Shift days)
Dublin
Dublin
Quality Specialist
Dublin
Dublin
Project Manager - R&D
Galway
Galway
Senior R&D Engineer
Dublin
Dublin
Quality Manager
Galway
Galway
Senior QA Associate (Shift)
Dublin
Dublin
Reliability Engineer
Tipperary
Tipperary
Mechanical Technician
Carlow
Carlow
Investigation Lead
Dublin
Dublin
Product Development Engineer
Galway
Galway
Senior QC Microbiology
Dublin
Dublin
Operations Engineer
Galway
Galway
Senior Operations Engineer
Galway
Galway
Material Handler
Carlow
Carlow
Senior Electronic Engineer
Dublin
Dublin
R&D Director
Galway
Galway
R&D Engineer
Galway
Galway
R&D Program Manager
Dublin
Dublin
Senior R&D Engineer
Galway
Galway
QA Manager
Canada
Canada
Production Operator
Meath
Meath
R&D Manager
Galway
Galway
Quality Engineer
Galway
Galway
Quality Technician
Dublin
Dublin
Senior QC Associate
Dublin
Dublin
Quality Engineer
Athlone
Athlone
Quality Control NPI Senior Associate
Dublin South
Dublin South
Process Chemist
Limerick
Limerick
Senior Equipment Engineer
Dublin
Dublin
Quality Director
Galway
Galway
Engineering Shift Technician
Dublin
Dublin
Quality Systems Manager
Dublin
Dublin
MS&T Associate Director
Dublin
Dublin
Quality Control Technician
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Quality Assurance Engineer
Longford
Longford
Quality Specialist
Dublin
Dublin
Project Manager - R&D
Galway
Galway
QC Laboratory Technician
Carlow
Carlow
Program Manager
Galway
Galway
Project Scheduler
Louth
Louth
Change Control SME
Cork
Cork
Quality Specialist
Clare
Clare
Maintenance Technician
Carlow
Carlow
Senior R&D Engineer
Galway
Galway
Product Development Engineer II
Athlone
Athlone
Apply for this job
Details
Senior Quality Engineer-Remote
Reference: | JCAO0603 | Location: |
Republic of Ireland |
Qualification: | Degree | Experience: | 5-7 Years |
Job Type: | Permanent | Salary: | Not Disclosed |
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.
- 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
Cork City Supply Chain Microbiology Biotechnology Engineering Medical Device Dublin Scientist Academic Project Manager Pharmaceutical Medical Affairs Cork Packaging Engineer Life Science Quality Engineering Scientific Chemistry PhD Mayo Allied Healthcare Connected Health Validation Engineer Manufacturing Executive Supply Chain Academic Limerick Quality Assurance Pharma Sales Biopharmaceutical Quality Control Sales and Marketing Diagnostics Product Development Engineer IT Sales and Marketing Clinical Research Laboratory Scientist
Group sites:
Medical Affairs Jobs | Clinical Research Jobs | Scientific Jobs | Connected Health Jobs | Pharmaceutical Jobs | Contract Jobs | Supply Chain Jobs | Medical Device Jobs | Science Jobs | Quality Assurance Jobs | Engineering Jobs | Biopharmaceutical Jobs | Biotechnology Jobs | Chemistry Jobs
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS
Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
Valid XHTML - CSS






