Quality Engineer [EL]

The Senior Quality Engineer is responsible for driving product and process quality through structured problem-solving, root-cause analysis, corrective and preventive actions (CAPA), process validation and continuous improvement initiatives. The role works closely with Production and cross-functional teams to maintain product conformity, improve process capability and ensure compliance with applicable quality and regulatory requirements.

Key Responsibilities

1. Root-Cause Analysis and CAPA Management

• Lead investigations into product and process non-conformances using structured problem-solving methodologies, including 5 Whys, Fishbone Analysis, FMEA and other root-cause analysis tools.
• Drive corrective and preventive action (CAPA) activities and ensure actions are implemented effectively and sustainably.
• Work with relevant departments to identify recurring quality issues and prevent their recurrence.
• Monitor CAPA effectiveness and ensure timely closure of corrective actions.

2. Process Validation and Quality Assurance

• Support Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) of equipment, manufacturing processes and test methods.
• Work closely with Production to investigate process failures, analyse quality data and maintain product conformity.
• Review validation results and support the implementation of appropriate process controls.
• Ensure manufacturing processes consistently meet established quality requirements.

3. Process Quality and Performance Improvement

• Monitor and improve process capability, stability, production yield and defect performance.
• Apply quality engineering tools, including Statistical Process Control (SPC), Measurement System Analysis (MSA) and Failure Mode and Effects Analysis (FMEA).
• Analyse quality trends and identify opportunities to reduce defects and improve manufacturing performance.
• Drive continuous improvement, Lean and Kaizen initiatives to enhance process efficiency and product quality.

4. Quality Compliance and Risk Management

• Support internal, customer and regulatory audits.
• Assist in ensuring compliance with applicable quality management systems and regulatory requirements.
• Support product and process risk management activities in accordance with ISO 14971.
• Identify potential quality risks and recommend appropriate mitigation measures.

5. Quality Reporting and Documentation

• Prepare quality performance metrics, trend analyses and management reports.
• Monitor key quality indicators and provide updates on quality improvement activities.
• Maintain accurate records of investigations, CAPA, validation activities and quality documentation.
• Present quality findings and improvement recommendations to relevant stakeholders.

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