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
Joan O'Malley
Life Science

0871897333
[email protected]
Connect with me on
Hot Science Jobs
Clinical Trial Capabilities Associate -
Cork
VP of R&D
Republic of Ireland
Senior Electronic Engineer
Dublin
Sourcing Associate - Parenteral Manufact
Cork
R&D Engineer
Galway
Automation Engineer
Waterford
Global Logistics Specialist
Dublin
PHD Chemist
Dublin
Regulatory Affairs Specialist
Republic of Ireland
Head of R&D
Galway
Senior Regulatory Affairs
Galway
Marketing Executive (US & Export Mar
Dublin
Project Engineer
Limerick
C&Q Engineer
Dublin
Quality Engineer
Cork
Manufacturing Engineer
Galway
Publications Scientific Communications A
Cork
Graduate Engineer
Limerick
NPI Quality Engineering Manager
Dublin
Mechatronics Engineer
Galway
Maintenance Technician
Kildare
NPI Manager
Dublin
Senior Behavioural Scientist
Dublin
Senior CSV Specialist- Hybrid/Remote
Republic of Ireland
Process Validation Engineer
Cork
Medical Approver Associate-Fluent German
Cork
Senior Automation Engineer
Galway
R&D Manager
Limerick
Sourcing Associate - Capital Projects
Cork
Design Assurance Engineer
Galway
Principal Human Factors Engineer
Dublin
Snr Process Engineer
Limerick
Clinical Development Director (Oncology)
Dublin
Quality Consultant/Manager
Republic of Ireland
Senior Quality Engineer
Limerick
Process Engineer
Limerick
Director of Regulatory Affairs
Dublin
Director of Technical Operation
Galway
CQV Engineer (Hybrid/ Remote)
Dublin
Director of Regulatory Affairs
Dublin
Controls Technician Nights
Galway
Senior Regulatory Affairs Specialist
Westmeath
Quality Engineer II
Galway
Publications Scientific Communications A
Cork
Senior Regulatory Affairs Specialist
Galway
Director Combination Product Development
Dublin
Senior Design Quality Engineer
Galway
Senior Packaging Development Engineer
Dublin
Senior Vision & Automation Engineer
Galway
Quality Systems Engineer
Galway
QA Manager
Dublin
Design Quality Engineer
Galway
QA Specialist
Dublin
Principal Respiratory Scientist
Dublin
Senior EHS Specialist
Cork
Person in Charge
Roscommon
EHS Specialist
Limerick
Senior Quality Engineer
Dublin
Senior Scientist
Dublin
Controls Technician Nights
Galway
R&D Engineer
Limerick City
Global Supply Chain Analyst
Limerick
Account Manager/ Process Service Technic
Cork
Director of Operations
Galway
Clinical Trials Project Manager
Cork
Senior Product Manager (Healthcare)
Dublin
Controls Automation Engineer
Galway
Manufacturing Quality Team Lead
Waterford
Controls Automation Engineer
Galway
Medical Device Project Manager- Remote
Westmeath
Exploratory Medicine and Pharmacology Ma
Cork
Electronic Product Test Engineer-Hybrid/
Republic of Ireland
Quality - Tech Transfer Specialist
Cork
Maintenance Technician Nights
Galway
Senior R&D Engineer
Dublin
Senior Validation Engineer
Limerick
Clinical Trials Start Up Associate Fluen
Cork
Project Manager - Fully Remote - Value
Republic of Ireland
Manufacturing Engineer
Galway
R&D Director
Galway
Validation Engineer
Wicklow
PLC Programmer/ Controls Engineer
Galway
Validation Engineer
Limerick
Associate Director Proj Mgmt (Tech Ops)
Waterford
QC Analyst
Cork
Validation Engineer
Cork
Microbiology Manager
Waterford
Design Assurance Engineer
Galway
Technical Operations Engineer
Cork
Product Development Scientist
Galway
Senior Packaging Engineer
Cork
R&D Senior Program Manager
Galway
Senior Quality Manager
Dublin
Senior Manager Clinical Operations
Dublin
Senior Clinical Data Management Associat
Dublin
Clinical Trial Associate German Speaking
Cork
R&D Technical Lead
Limerick
Senior R&D Project Manager
Limerick City
Engineering Technician
Dublin South
Validation Engineer
Cork
Senior Project Engineer
Cork
Optical Scientist
Galway
Senior QA Engineer
Dublin
PLC Programmer/ Controls Engineer
Galway
Clinical Trials Contracts and Budgets As
Cork
Manufacturing Engineer
Cork
Director of Regulatory Affairs
Galway
Process Engineer
Republic of Ireland
Senior Associate Scientist/ Analyst
Cork
Publications Scientific Communications A
Cork
Senior R&D Engineer
Limerick City
Clinical Trials Contracts and Budgets As
Cork
Contract & Budgets Trial Capabilitie
Cork
Senior Quality and Regulatory Manager
Galway
Senior Manufacturing Engineer
Cork
Process Engineer
Offaly
Technical Operations Manager
Dublin
QA Specialist
Cork
Quality Engineer
Limerick
Quality Director
Dublin
Project Engineer
Limerick
Field Service Engineer (Pharmaceutical)
Limerick
Project Engineer
Limerick
Strategic Account Manager (B2B - Medical
Dublin
R&D Manager
Galway
Clinical Trial Associate
Dublin
Quality Systems Engineer
Galway
Senior Quality Engineer
Dublin
Senior Electronic Engineer
Limerick
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

Quality Systems Engineer


Reference:JOM/AXXF-700335 Location: Kildare
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, Quality Systems Engineer

JOM/AXXF-700335

Quality Systems Engineer

Location Kildare

Area Medical Device

The purpose of this role is to support the Quality Manager during a development phase of this high-volume manufacturing plant. The role will involve liaising across the organisation to ensure internal system compliance and customer specifications are achieved. It will also demand the timely and effective closure of internal/external quality issues in a culture of compliance and continuous improvement.

Responsibilities:

  • Lead auditee for Regulatory, Customer and Corporate audits.
  • Complaint trending and monitoring of corrective actions in order to drive continuous improvements.
  • Maintenance & communication of GMP standards throughout the plant.
  • Produce and maintain appropriate procedures to ensure compliance with regulatory requirements.
  • Manage / execute site quality systems including CAPA, internal and supplier auditing and change control activities
  • Complete management review and close out on any actions identified.
  • Compile and execute validation protocols for the manufacturing processes and equipment of existing and new products. Ensure correct use of statistical QA methods into the production environment and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
  • Owner of batch release process in accordance with internal procedures.

Qualifications:
  • 3rd level Qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Engineering role.
Competencies and Attributes:
  • Experience working with an ISO13485:2016 compliant quality system essential.
  • Lean/Six Sigma Training advantageous. Strong problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
  • Self-directed and results driven team player. Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
  • Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organisation.
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.


Contact Joan O’Malley at 087-1897333 for more details.