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Biostatistician
Dublin City Centre
Administration Support
Dublin North
Supply Chain Analyst
Dublin North
QA Manager
Dublin North
R&D Engineer
Galway
API Purchaser
Dublin
QA Manager
Meath
Program Manager
Westmeath
R&D Engineer
Dublin
Senior Buyer
Dublin
QA Manager
Dublin West
Automation Technician
Dublin South
QC Manager
Galway
Snr QA Specialist
Dublin South
QA Manager Biologics
Dublin West
Consultant
James Cassidy
Life Science

+353 1 5079250
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Other similar job titles you may be intertested in include: Senior Quality Engineer Customer Complaints Quality Systems Engineer

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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