Senior Quality Engineer

Job Title

Job Description

Job Responsibilities:

• Analyzes defects for determining dispositions of non-conformances and drives management of Non-Conformances (NC) and Quality Notifications (QN) and implements effective Corrective and Preventive Actions (CAPA) actions.
• Helps to conduct the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities.
• Supports operations performance monitoring, risk assessment, reporting, improvement and development, aids with improvement programs in factory, and supports analytical testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing.
• Coordinates timely quality engineering and quality assurance tasks, aids in ensuring manufacturing quality systems are maintained, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
• Possesses working knowledge of generic products/services and Quality Engineering and Continuous Improvement techniques, exercises judgment within defined procedures and policies to determine appropriate action, and frequently interacts with supervisors and functional peer groups to gain cooperation of others.
• Develops a multi-disciplinary approach and knowledge of basic principles relevant to quality engineering, theories and concepts, initiating process improvement activities.
• Identifies transformative process enhancement opportunities, facilitating the execution of advanced improvement initiatives to optimize operational performance and elevate product quality benchmarks significantly.
• Applies advanced statistical analysis techniques proficiently to interpret complex data trends and resolve medium to high complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.
• Ensures the comprehensive execution of intricate process validation protocols, meticulously coordinating multifaceted production activities to bolster process validation efforts and drive continuous process improvements effectively.
• Prepares and delivers detailed quality metrics and reports to key stakeholders, highlighting significant achievements, emerging trends, and targeted areas for advanced improvement initiatives and regulatory compliance strategies.
• Participates in investigations and collaborates with suppliers, Research and Development (R&D), and manufacturing teams to resolve quality issues and maintain high standards throughout the supply chain. Minimum required Education: Bachelor's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education. Minimum required Experience: No prior experience required with Bachelor's OR minimum 4 years of experience in Quality Engineering, Safety Engineering, Process Engineering or equivalent with Vocational Education. Minimum required Certification: N/A Preferred Education: N/A Preferred Experience: N/A Preferred Certification: N/A Preferred Skills:
• Process Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Regulatory Requirements
• Manufacturing Processes
• Process Monitoring
• Privacy, Safety and Security Risk Assessment
• Technical Documentation
• Process Engineering
• Continuous Improvement