Telephone: 086 8395533
Senior Design Assurance Engineer
Our client, a medical device company in Wexford is currently looking to recruit a Senior Design Assurance Engineer for their site.
The Senior Design Assurance Engineer will be responsible for developing, maintaining and improving standardised 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. When ISO 11070 is updated, review current test protocols and check compliance and where applicable be capable of running and managing improvement projects in relation to current test protocols to stay in compliance to ISO 11070.
The role will also be responsible for developing, maintaining and improving a standardised validation process for the Plant to ensure compliance to required regulations.
- 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.
- Validation documentation;
- 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.
- Provide cover for the QA Lab in relation to testing and aid in the smooth running of the lab.
- Plant audits;
- Interacting and presenting validation documentation during FDA, NSAI, Corporate and customer audits.
- Conduct training in Validation Methodologies and related procedures as required.
- Ensure that in your absence, your area of responsibility is covered. Ensure that other departments are informed of your arrangements.
- Be an active member of the team and work with all employees to develop a world class lean manufacturing system.
- Comply with the behavioural standards.
- Ability to communicate and work with people inside and outside the department.
- Good communicator (written and oral).
- Ability to train and lead where required.
- Ability to co-ordinate, plan and organise in a timely manner.
- Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
- Rigorous attention to detail.
- Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role.
- 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.
For further information on this Regional Compliance Auditor role in Wexford please contact Bimi on 086 8395533 / email@example.com
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