Production Quality Engineer (West / Medical Device Manufacturing) [SAS]

Lead investigations into product and process non-conformances using structured root-cause analysis methodologies, including 5 Whys, Fishbone and FMEA.

Oversee CAPA activities, ensuring corrective and preventive actions are effectively implemented and sustained.

Support equipment, manufacturing process and test method validations, including IQ/OQ/PQ.

Work closely with Production teams to troubleshoot process failures, analyse data and ensure product conformity.

Monitor and enhance process capability, stability, production yield and defect performance.

Apply quality engineering tools and methodologies, including SPC, MSA and FMEA, to maintain process control.

Drive continuous improvement initiatives through Lean Manufacturing and Kaizen methodologies.

Coordinate and support internal, customer and regulatory audits.

Prepare quality performance metrics, conduct trend analysis and generate management reports.

Support risk management activities in compliance with ISO 14971 requirements.

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