Senior Validation Engineer

Senior Validation Engineer
  • £50,000 - £65,000 per Annum
  • Permanent
  • London, England, UK W12 7RZ London London UK W12 7RZ
Job Ref: J2160491
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 26 May 2021
Senior Validation Engineer - London - Permanent

Senior Validation Engineer - London - PermanentSRG are currently recruiting for a Senior Validation Engineer to join a Medical Technology company in London on a permanent basis at a competitive salary and benefits package, depending on experience. Primary Responsibilities* Help to transfer paper based QMS into electronic QMS system. * Create QMS documentation and help other members of staff to create/update required QMS documentation to apply for ISO 13485 certification.* Become an SME for the electronic QMS system to help other users.* Create and maintain the Validation Master Plan for equipment, process, software, and product for the company globally.* Take the lead on validation activities for the equipment, processes and software related to product design together with creation and execution of validation protocols, reports, CSV, URS, and other appropriate documentation according to the company's global templates.* Create a plan for necessary revalidation activities based on risk assessment for all equipment, processes, and software. * Handle changes according to SOPs and work cross functionally with other teams to fulfil necessary actions and documentation needs to stay in compliance with relevant standards and regulations.* Perform audits of processes as Lead Auditor according to current version ISO 13485 and FDA 21 CFR Part 820 as well as participate on Supplier and third-party Audits.Qualifications and Experience: Education:Degree or equivalent in an Engineering, Science or Clinical subjects or at least 3 years' experience in the Medical Device (MD) and or In-Vitro Diagnostics (IVD) industries in similar position.Skills:* Strong knowledge of ISO 13485 and US FDA 21 CFR Part 820 * Strong organizational and problem-solving skills in a fast-paced environment* Ability to work to tight deadlines and deliver exceptional work when required* Be fully computer literate - Microsoft Office Pack Skills - necessary* Knowledge of the Medical Device Regulation and/or In-Vitro Diagnostics * Regulation and US FDA 21 CFR Part 11 would be advantageous but not requiredExperience:Performing Validation and Change control activities in MD and/or IVD or similar industry is necessaryPerforming risk management activitiesNCR and CAPA managementDocument control and other QMS activitiesFor more information, please call Laith Mustafa on 0161 868 2231 or email

25/06/2021 14:27:26
GBP 50000 65000 Annum
Contact Consultant:
Laith Mustafa

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