Senior Engineer Quality Management Process

Responsibilities

• Lead the development, implementation, and continuous improvement of quality management processes in Lab operations
• Conduct comprehensive process analysis and root cause analysis to identify deviations and bottlenecks
• Monitor key performance indicators (KPIs) and quality metrics to drive data-driven decision-making
• Develop and execute corrective and preventive action (CAPA) plans
• Ensure compliance with relevant quality standards, regulations, and certifications
• Gauge management and calibration to support manufacturing
• Mentor and guide junior engineers on quality management best practices
• Prepare and maintain documentation of quality procedures, work instructions, and process maps
• Present findings and progress reports to senior management and stakeholders
• Work collaboratively with cross-functional teams to enhance operational efficiency

Requirements

• 2+ years of professional experience in quality engineering, quality assurance, or quality management
• Strong analytical and problem-solving skills
• Proficiency in root cause analysis and CAPA implementation
• Basic understanding of ISO 9001, ISO 14001, or equivalent standards
• Experience with quality management software and data analysis tools
• Excellent technical documentation and communication skills
• Proficiency in quality management methods (FMEA, 4M, 14-Q-Basics)
• Knowledge of IATF, ISO, and VDA standards
• Advanced skills in MS Excel, PowerPoint, and Power BI

Preferred Qualifications

• Experience with ERP systems
• Experience with statistical analysis software