Quality Assurance Engineer [EL]

• Lead investigations into product and process quality issues using 5 Whys, Fishbone Analysis and FMEA.
• Manage CAPA activities and ensure corrective actions are effective.
• Support IQ, OQ and PQ validation of equipment, manufacturing processes and test methods.
• Work with Production teams to resolve quality issues and maintain product conformity.
• Monitor and improve process capability, stability, production yield and defect rates.
• Apply quality tools such as SPC, MSA and FMEA.
• Drive continuous improvement, Lean and Kaizen initiatives.
• Support internal, customer and regulatory audits.
• Prepare quality reports, performance metrics and trend analyses.
• Support product and process risk management in accordance with ISO 14971.

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