QC Methods Engineer
On-siteShildon, England, United Kingdom
Job Summary
Manage QC procedures, SOPs, and metrics within the electronic Quality Management System (ETQ) and support systems including QPulse, LIMS, and Gemba. Analyze quality and laboratory performance data to identify trends, perform Statistical Process Control (SPC) analysis, and lead root cause investigations using methodologies such as 5 Why, Ishikawa, and 8D. Implement corrective and preventive actions (CAPA) and lead equipment qualification, calibration management, and maintenance programs. Plan and conduct internal audits covering quality systems, documentation, and safety while supporting customer and regulatory audits. Collaborate with QA, Operations, and Engineering teams on non-conformances, process improvements, and validation activities.
Required Qualifications
- Experience working within a Quality Control environment for over 5 years
- Knowledge of ISO 9001, AS9100, or equivalent quality management standards
- Over 5 years experience working in a highly regulated environment (Pharma/Food/labs)
- Experience using data analysis to inform improvements with test methods
- Structured background using Root Cause Analysis & CAPA
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