Manufacturing Quality Engineer

Responsibilities

• Support daily manufacturing operations to ensure compliance with quality standards and procedures.
• Investigate product defects, non-conformances, deviations, and customer complaints.
• Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.
• Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
• Analyze quality metrics and identify opportunities for continuous improvement.
• Review and approve manufacturing procedures, work instructions, SOPs, and quality documentation.
• Support process validation, equipment qualification, and change control activities.
• Conduct internal audits and participate in customer, regulatory, and certification audits.
• Collaborate with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams.
• Monitor Statistical Process Control (SPC) data and implement process improvements.
• Ensure compliance with applicable regulations and quality standards.
• Support risk management and quality planning activities.

Requirements

• Bachelor's degree in mechanical, Industrial, Manufacturing, Biomedical Engineering.
• 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
• Experience in a manufacturing environment.

Skills

• Quality Management Systems (QMS).
• CAPA Management.
• Root Cause Analysis.
• Non-Conformance Management.
• Change Control.
• Statistical Process Control (SPC).
• FMEA (Failure Mode and Effects Analysis).
• Risk Management.
• Process Improvement.
• Data Analysis and Reporting.
• Technical Documentation.