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QA Manager
Dublin West
QA Manager
Dublin North
QA Manager
Meath
QA Manager
Dublin
Consultant
Cork
API Purchaser
Dublin
Buyer
Dublin
Snr QA Specialist
Dublin South
Administration Support
Dublin North
R&D Engineer
Dublin
R&D Engineer
Galway
Quality Assurance Manager
Republic of Ireland
Quality Engineer
Dublin South
Project Engineer
Dublin North
Supply Chain Analyst
Dublin North
Biostatistician
Dublin City Centre
National Sales Representative
Republic of Ireland
SAP Planner
Galway
QA Manager Biologics
Dublin West
CTO
Galway
Program Manager
Westmeath
Risk Manager
Dublin
QC Manager
Dublin
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Dublin
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James Cassidy
Life Science

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

VP Quality Assurance & Regulatory Affairs

VP of Quality Assurance & Regulatory Affairs Life Science Recruitment are currently sourcing an VP of Quality Assurance & Regulatory Affairs for a MedT

Location: Galway,
VP Quality Assurance & Regulatory Affairs
Galway Not Disclosed
Other Quality Engineering Jobs
Job Title Location Salary Actions
Senior Quality Engineer - Team Leader Limerick 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