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Program Manager
Westmeath
Biostatistician
Dublin City Centre
QA Manager
Dublin North
R&D Engineer
Galway
QA Manager Biologics
Dublin West
Snr QA Specialist
Dublin South
Product Specialist (Microbiology)
Republic of Ireland
Market Access Manager
Dublin City Centre
QA Manager
Dublin West
QA Manager
Meath
QP Biologics
Dublin
Snr Process Engineer
Dublin North
Consultant
James Cassidy
Life Science

+353 1 5079250
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Search Results for Design Assurance
Job Title. Location Salary Actions

Test Method Development Scientist

Test Method Development Scientist Our Dublin based client requires a Test Method Development Scientist to join their team on a permanent basis. This is an excellent opportunity to work cross functionally and gain in depth experience of device development. Responsibilities • Responsible for comparator product activities within the group, including building and maintenance of the physical and electronic library and comparator testing • Perform mechanical and functional testing on medical devices and combination products using standard and bespoke techniques develope...

Location: Dublin,
Test Method Development Scientist
Dublin Not Disclosed

Balloon Development Engineer

Balloon Development Engineer Our Client, a global medical device organisation requires a Balloon Development Engineer to join their team on a permanent basis. The ideal candidate for this role will have balloon forming or extrusion experience. Responsibilities • Responsible for the development of new and existing balloon products from initial concept through to completion as part of a project team • Develop a robust production process for the manufacture of new balloons, optimising processes to maximise balloon performance, and minimise process cost • D...

Location: Galway,
Balloon Development Engineer
Galway Not Disclosed
Other Quality Engineering Jobs
Job Title Location Salary Actions
Quality Systems Engineer Limerick Not Disclosed
Senior Sterilisation Quality Engineer Westmeath Not Disclosed
Senior Sterilisation Quality Engineer Westmeath Not Disclosed
Post Market Surveillance Specialist Westmeath Not Disclosed

Design Assurance Career Profile

Design Assurance


Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.

Role/Responsibility

  • Support risk management activities
  • Evaluation of new products, assuring the safety and efficacy of the devices
  • Design verification and shelf life protocols / reports
  • Qualification and validation activities
  • Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
  • Adhere to Quality System and Design Control requirements
  • Root cause investigations; drive problem solving efforts for quality issues
  • Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
  • Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
  • Support customer complaint analysis and post market surveillance activities
  • Generate and approve change requests

Skill/Experience

  • Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
  • A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
  • A minimum of 1 years experience in product & process development