Quality Engineer
£45,000 - £50,000
Surrey
The role of Quality Engineer is to Support the on-site Medical Device manufacturing operations through participation in the calibration, maintenance and validation processes for production equipment.
Responsibilities:
- Develop and maintain compliance with the Quality Management System
- Ensure that non-conforming product is routed through the appropriate sub-systems in line with documented procedures
- Support other Quality Engineer’s in functions as required
- Assist in the investigation and analysis of internal failures and customer complaints
- Interpret engineering drawings, schematic diagrams, formulas or specifications and confer with engineering staff to determine quality and reliability standards
- Undertake scheduled internal and supplier audits as assigned by the QA / RA Manager
- Liaise with suppliers on quality issues
- Review product metrology for supplier part approvals (FAI, capability studies, SPC reports) to agreed schedules
- Evaluate precision and accuracy testing and measurement of supplier production equipment (MSA / R&R studies)
- Perform trend analysis and generate reports for supplier performance
Requirements:
- Knowledge of Good Manufacturing Practice (GMP) and applicable quality system standards
- Experience in the medical device industry in a Quality capacity
- Auditing experience
- Understanding of supplier quality