Process Quality Engineer [EL]

• Lead root-cause investigations for product and process non-conformances.
• Drive CAPA implementation and effectiveness verification.
• Support equipment, process and test method validation (IQ/OQ/PQ).
• Work closely with Production to resolve quality issues and improve product conformity.
• Monitor process capability, yield and defect performance.
• Apply quality engineering tools, including SPC, MSA and FMEA.
• Lead continuous improvement, Lean and Kaizen activities.
• Support internal, customer and regulatory audits.
• Prepare quality performance reports and conduct trend analysis.
• Support risk management activities in accordance with ISO 14971.

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