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Process Engineer
Dublin North
Planner
Limerick
eClinical Project Manager
Republic of Ireland
Clinical Research Associate (CRA)
Republic of Ireland
QP Manager
Dublin
R&D Manager
Galway
QC Scientist
Limerick
C&Q Engineer
Dublin
Operations Lead/ Engineer
Republic of Ireland
Operations Lead/ Engineer
Republic of Ireland
Senior Lab Analyst
Waterford
R&D Manager
Limerick
Project Engineer
Limerick
Qualified Person
Waterford
Project Engineer
Limerick
Process Engineer
Limerick
Quality Engineer
Limerick
Senior Planner
Limerick
Project Manager
Limerick
Validation Lead
Limerick
Technical Writer
Limerick
R&D Engineer
Limerick City
Head of R&D
Galway
Senior R&D Engineer
Limerick City
QA Manager
Dublin
Business Program Lead - Remote
Republic of Ireland
QA Manager
Cavan
eClinical Project Coordinator
Republic of Ireland
Project Engineer
Limerick
Consultant
James Cassidy
Life Science

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

Industrial Product Designer

Industrial Product Designer Our client, an Irish based start-up company are currently recruiting for an Industrial Product Designer to join their team on a permanent basis. This is a very exciting opportunity to join this organisation in its infancy. Responsibilities Support the development of the product strategy and roadmap to ensure a competitive offering that aligns with evolving consumer and market needs and corporate priorities Managing consumers product development process from idea generation to delivery. This includes assessing and prioritising needs, creating com...

Location: Dublin,
Industrial Product Designer
Dublin Not Disclosed

Senior Design Assurance Engineer

Senior Design Assurance Engineer Our client a Galway based Medical Device company currently seeks a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new technologies Role/Responsibilities Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality...

Location: Galway,
Senior Design Assurance Engineer
Galway Not Disclosed
Other Quality Engineering Jobs
Job Title Location Salary Actions
Quality Systems Specialist Cork Not Disclosed
Team Leader - Vendor Management Waterford Not Disclosed
Senior QA Engineer Dublin 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