Under the direction of the site Quality Manager or Technical Quality Manager within our international medical device client, and as a member of the Quality Operations team, the Validation Engineer will play a critical role in the development and execution of key quality engineering plans and strategies.
Engaging in the following plant quality engineering areas: Product transfers, validation, process control improvement activities, customer complaint investigations, major failure investigations, and statistical techniques in support of operations.
- The Validation Engineer will directly support site validation program (product, process, equipment and software, test methods)
- Leads Root cause analysis and implementation of corrective action for process related concerns
- Assist the Quality Manager or Quality Systems lead in establishing, implementing, maintaining, and improving the quality management system
- Develop and implement continuous improvement activities to enhance the quality system, such as Six Sigma, 5S, Lean Manufacturing methods, etc.
- The Validation Engineer will develop and implement technical quality training to build internal capability in areas of expertise such as risk management per ISO 14971, validation, statistical techniques, Quality sampling plans, RCA and investigation, etc...
- Supports development and improvement of inspection methods, including but not limited to Test Method Validation
- Interface with Engineering and Operations to ensure new product transfers to Production are in accordance with approved protocols
- Support Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system
- Drive resolution of failure analysis, corrective and preventive action to respond to internal and/or external customer complaints
- The Validation Engineer will conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions
- Manage individual complaint investigation workflows into a comprehensive summary of the findings for inclusion in complaint files and ensure timely evaluation, escalation, and closure of complaint files
- Ensure timely resolution of customer complaints, supplier failure, corrective actions and preventive actions
- Bachelor's degree in Science or Engineering discipline (or equivalent track record in a Validation Engineer role)
- Relevant Medical Devices experience is preferred
- Leadership exposure
- Quality system maintenance is preferred
- Medical Device (PFMEA, Control Plan, CAPA) etc.
- Knowledge of ISO 9001 and ISO 1348
- Working in a GMP environment such as Medical Device industry or plastic consumables
- Statistical Analysis Tools such as Minitab or JMP, SAP, TrackWise, Microsoft Excel, Visio, Power Point, and MS Project preferred
- ASQ Certified Quality Engineer is preferred or similar certification
- Six Sigma Certification is desirable
- Lean Manufacturing working experience
To find out more about Real please visit www.realstaffing.com
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