The Quality Engineer II supports assignment area providing Quality Engineering input and direction to ensure product quality and continuous improvement in the areas of validation, compliance and production throughput.
- Use Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
- Support process investigations providing formal structured approach to identify root causes, establishes corrective actions and execute prevention plans in products and/or processes.
- Employ appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
- Ensures effective quality strategies are created for the validation of equipment, test methods and processes as well as master validation plans and risk management documentation in accordance with regulatory requirements and internal requirements.
- Provides guidance on the preparation and execution of computer software validation protocols, test scripts and reports to ensure all Computer System Validation (CSV) requirements are met Reviews Analytical Methods and Specifications, Validation Protocols, Deviations, Investigations, Impact Assessments and other forms of Quality documentation as assigned.
- Provide quality input and support to the manufacturing area and participate in key initiatives and projects.
- Drive preparation and actively participate in external audits by Notified Bodies and Health Authorities, where necessary.
Bachelor's degree from an accredited institution in a technical discipline
- Min 2 years experience in Quality Engineering
- Knowledge of FDA, medical device, GMP and validation requirements
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Real 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