Design Assurance Engineer - Ivdr

Abbott

Galway, Ireland
Not specified; base pyy n/a; range may vary by loc...
Not specified (assumed to be hybrid or onsite based on industry norms)
Iso13485 fda regulated environment experience
2-3 years quality engineering or design assurance
Primary degree in science engineering or technology
Abbott is seeking a Design Assurance Engineer for a 12-month fixed-term contract in Galway, Ireland, to support its Infectious Diseases Emerging Market Business Unit. The role focuses on enhancing design control processes for new product development within a regulated environment, requiring collaboration across various teams

Job Summary

  • This role supports the global Design Assurance team for Abbott's Infectious Diseases Emerging Market Business Unit to ensure compliance throughout the product lifecycle.
  • The engineer will lead remediation of design control procedures to standardize practices across sites and facilitate cross-functional collaboration with R&D, QA, and RA teams.
  • Responsibilities include performing technical reviews, managing risk documentation, and supporting internal and external regulatory audits such as FDA and WHO inspections.

Matching Summary

Match Score: 85

Abbott is seeking a Design Assurance Engineer for a 12-month fixed-term contract in Galway, Ireland, to support its Infectious Diseases Emerging Market Business Unit. The role focuses on enhancing design control processes for new product development within a regulated environment, requiring collaboration across various teams.

Salary

Not specified; Base pay N/A; Range may vary by location

Skills & Requirements

Must-have

  • ISO13485 FDA regulated environment experience
  • 2-3 years Quality Engineering or Design Assurance
  • Primary Degree in Science Engineering or Technology

Nice-to-have

  • Formal training in Risk Management and Validation
  • Experience with Lateral Flow Diagnostic Devices
  • Excellent virtual communication and workshop leadership

Key Requirements

  • Primary Degree in Science, Engineering, or Technology
  • 2-3 years experience in regulated Quality Engineering
  • Knowledge of ISO13485 and FDA regulations

Work Rights

Not specified

Tailored Resume

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