Senior Process Engineer
4 days ago
**Senior Process Engineer**
Our client is a global medical technology company developing, manufacturing and distributing a variety of medical devices is looking for a Process Engineer to join the team. This company operates worldwide and has grown to over 500 people.
The Process Engineer will be responsible for the day to day production, assist design and implementation of production & testing and support quality compliance across the company.
**Responsibilities**:
- Day to Day Production Support
- The Process Engineer will need to assist in the provision and analysis of manufacturing data i.e., production control charts, reliability, and process capability to improve the process and monitor and measure against targets.
- Timely completion of maintenance and calibration of all critical equipment to schedule
- New equipment and process introduction and validation.
- Assist in the design and implementation of production & testing gauging and manufacturing aids
- Liaising with equipment, component and tooling suppliers to support and improve manufacturing processes.
- Completion of validation master plan activities to schedule.
- Generation and execution of study protocols and reports to support regulatory requirements.
- The Process Engineer will support design transfer and design change processes from new product development to production
- Creation, improvement and update of quality system and production documentation
- Creation and update of technical drawings
- Support continuous improvement activity within Quality and Production and support quality compliance across the company
- Support Investigation of quality issues, root cause analysis and CAPA implementation & verification.
- Effective and timely change management and implementation.
- Auditing to ISO 13485 and FDA 21 CFR Part 820
- Provide equipment and process training as required.
**Requirements**:
- Qualification in Engineering or equivalent to experience
- Experience in a regulatory controlled manufacturing
- Experience of fault finding and implementing corrections and / or improvements in manufacturing processes
- Experience of fault finding and repair with electro-mechanical equipment
- Experience of jig and fixture design and procurement for high precision manual and semi-automated assembly processes
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 andWales
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