Senior Validation Engineer
Brewster Partners are recruiting for an established and market leading manufacturing business based in Leeds. As the Senior Validation Engineer you will report directly into the Operations Manager, the successful candidate will be responsible for managing and leading all quality activities within the site in addition to driving quality improvements across the organisation.
Must have excellent knowledge and ability to validate medical machinery.
- Scopes, plans, and leads complex system, hardware, and disposables test development and product verification efforts.
- Develops product verification strategies that ensure complete coverage of critical functionality and performance for new and changed products.
- Analyses technical files of existing products against quality system requirements, identifies gaps in verification approach, and develops plans to address the gaps.
- Designs, develops, and validates product performance test tools of high complexity. These tools may include standard test methods, hardware fixtures, manual and automated testing equipment, and data acquisition, data analysis, and control software.
- Demonstrates test method repeatability and reproducibility through GRR, MSA, and other analytical techniques.
- Prepares documentation for product verification and test development activities including plans, test diagrams, test design descriptions, protocols, traceability matrices, and reports.
- Manages product test execution activities and reports test anomalies for triage by the project team. Participates in root cause investigation and recommends in corrective actions.
- Analyses technical data using appropriate statistical techniques and communicates outcomes through clear, concise reporting.
- Manages the project verification schedule, resource plan, and keeps stakeholders up to date with status.
- Performs assignments independently with limited supervision as to expected results.
- Recommends improvements to the organizational test and verification SOPs and tools.
- Coaches and develops less experienced engineers. Necessary to support the operations of the Quality and Regulatory Affairs Department.
- Thorough knowledge of validation processes for machinery and products as per ISO 13485 and other ISO or international standards
- Management experience
- 5+ years in Quality department role
- ISO 13485 implementation experience
- Quality control/assurance background
- Manufacturing industry experience
- Technically astute, interpreting technical drawings
- Degree qualification in Bio-medical Engineering, Science, Mechanical Engineering or Manufacturing
£45,000 - £55,000 pa
Associate Key Account Director
Brewster Partners Recruitment Group
To apply for this job, please send your CV to the email above or to email@example.com quoting "Vacancy: Senior Validation Engineer, Reference: LG / BBBH15393". Thank you for your interest.