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Biostatistician
Dublin City Centre
QA Manager Biologics
Dublin West
QA Manager
Meath
R&D Engineer
Galway
QA Manager
Dublin West
Program Manager
Westmeath
Buyer
Cork
API Purchaser
Dublin
R&D Engineer
Dublin
Snr QA Specialist
Dublin South
QA Officer
Dublin
QA Manager
Dublin North
Head of Quality
Dublin West
Consultant
James Cassidy
Life Science

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

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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