Validation Engineer Medical Devices Cork

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As a Quality Validation Engineer you will be supporting the validation, change management, in process monitoring and maintenance of the special processes utilized as well as all other equipment validation work completed. Particular focus will be placed on the Critical In Process and Final Cleaning processes.CompanyMedical device company specialising in Orthopaedic products who are growing through an exciting growth phase.Responsibilities

- Characterization study/Diagnosis creation and execution when applicable.

- Review and execution of process validations related to special processes ensuring compliance to all internal requirements as well as FDA and ISO regulations.

- Review and approval of validation documentation related to all other new equipment.

- Identify and implement cost saving initiatives related to the validation process.

- Develop and implement comprehensive test plans as well as test methods to ensure that special processes are robust and remain within the validated state.

- Establish and track manufacturing requests relative to testing sample requirements

- Represent Quality Engineering Operations on validation related projects, give guidance on approach taken and establish associated reporting.

- Support QA and RA groups during audits, inspections and authorities responding when related to special processes and especially Critical In Process and Final Cleaning processes.Requirements

- Minimum Level 7 Degree level qualifications in a related technical discipline.

- Minimum of 4 years' experience working in a similar engineering role and/or have equivalent process validation experience.

- Technical knowledge on Critical Cleaning processes and the execution of ISO 19227 and related requirements.

- Lean and Six Sigma qualifications are an advantage.To learn more about this role please APPLY today with an up-to-date CV and your availability to take a call. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales