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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