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Validation Engineer

1 month ago

Galway, Galway, Ireland GxP Recruitment Full time

We are looking for a dynamic QA Validation Engineer for a long term contract with a leading medical device client in Galway.

Note: No sponsorship will be provided for this contract role. A validation Stamp 1G or Stamp 4 is required at minimum. Previous Medical Device experience required.

  • Prepare all lifecycle documentation required such as Functional Specifications, software design specifications, calibration specifications and other associated documentation required for equipment and systems.
  • Development and execution of validation documentation such as IQ/OQ/PQ, Test Method Validations
  • Test Method development, Development or modification of Test Method Validation protocols and reports
  • Development or modification of validation packages, design plans, and risk management deliverables (e.g. FMEAs).
  • Ensure software is controlled and stored as per validation procedure guidelines.
  • Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
  • Work with Quality department to ensure all validations are in line with validation standards.
  • Work with key stakeholders on all project deliverables.
  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.

Qualifications

  • Bachelor's degree in Life Science, Engineering, or closely related discipline is required
  • Previous Research & Development experience within the medical device industry is advantageous.
  • 5 years of QA documentation and validation experience within the medical device industry
  • Excellent communication, team and organizational skills required.
  • Ability to use own initiative and be proactive in the management of assigned tasks to set and meet deadlines.
  • Ability to work co-operatively and effectively with others to establish and maintain good working relationships.
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