Cache of job #13968172

Job Title

Senior Design Assurance Engineer/Validation Eng

Employer

Hartley People

Location

Wexford

Description

Our client, a leader in medical device manufacturing is currently seeking a Senior Design Assurance Engineer. This role is fantastic opportunity to gain experience across a number of areas within the business.  The Role: Ensure continued compliance with all Regulatory Standards. This includes: ISO 13485. ISO 11070. FDA QSR. Ensuring continued compliance with DMR. Process Validation Guidance from the Global Harmonization Task Force (GHTF) – July, 1999. Drive the site validation function in the development and provisions of documentation for the qualification (IQ/OQ/PQ/PPQ) related to agreed Plant validations. Working as a member of the plant project team to review what projects require validation. Assist with URS development for software validation projects. Interact with other departments conducting the validations before protocols are written and again to review the validation data for the validation report. Ensure that all data, results and information associated with qualification and validation data provided for reports are in accordance with written procedures. Implement, deploy and revise as applicable all Validation procedures. Assist in the development of Master Validation Plans and Validation Strategies. Ensure that the plant master validation list is kept up to date and that approved records for all the validations listed are available in hard copy for audits and that all are available to view on EDM. Provide a system for documenting the annual validation activities and the agreed schedule. Writing and arranging approval of validation protocols and reports; Update validation protocol/reports with deviations report.   Lead the clinical relevant validated test methods for all newly designed and newly introduced products that are agreed with the R&D and Engineering NPI groups in the planning phase of the project.  Plant audits; Interacting and presenting validation documentation during FDA, NSAI, Corporate and customer audits. Conduct training in Validation Methodologies and related procedures as required. The Person:  Engineering or science Degree. Knowledge of Computer System Validation will be a distinct advantage. A Six Sigma qualification will be a distinct advantage. Leader auditor qualification would be a distinct advantage. Knowledge of Test Method Validation will be a distinct advantage. Experience in Design Assurance with the ability to develop clinical relevant validated tests methods. Good PC skills and the ability to use Microsoft Project to track and manage significant projects.  Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Eamonn on 051-878813 or email your CV in response to this job posting.

Date Added

1946 days ago

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