Job Description:
Performs timely low to medium complexity quality technician and quality assurance tasks, assisting in ensuring manufacturing quality systems are maintained, and supports completion of New Product Introduction (NPI) and product transfers in factory. Supports 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. Contributes to risk assessment, operations performance monitoring, reporting, improvement and development, assists with improvement programs in factory, and supports testing and Supplier Quality Engineering (SQE), Supplier Quality Assurance (SQA) and Purchasing. Applies knowledge of products/services, Quality Engineering and Continuous Improvement techniques to identify key issues and patterns from available data, and formulates own interpretation regarding assignments based on calculations, and coordinates implementation of changes. Conducts process validation protocols, coordinates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities. Assists in the investigation of nonconformances, determines root causes, and implements effective Corrective and Preventive Actions (CAPA) actions, monitoring their impact and facilitating management of Non-Conformances (NC) and Quality Notifications (QN). Performs detailed audits of manufacturing processes to uphold quality standards and compliance with regulatory requirements. Utilizes Statistical Process Control (SPC) methods to monitor production processes, analyzing data trends, and proactively addressing deviations to prevent defects. Performs root cause analysis to investigate quality issues, identify underlying causes, and implement corrective actions to prevent recurrence.
Requirements
• Minimum required Education: High School Diploma, Vocational Education/ Bachelor''s Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• Minimum required Experience: Minimum 2 years of experience with Vocational Education in Quality Engineering, Safety Engineering, Process Engineering or equivalent OR no prior experience with Bachelor''s Degree
Preferred Skills
• Process Quality Management
• Data Analysis & Interpretation
• Design for Quality (DFQ)
• CAPA Methodologies
• Regulatory Requirements
• Manufacturing Processes
• Process Monitoring
• Privacy, Safety and Security
• Risk Assessment
• Technical Documentation
• Process Engineering
• Excel proficiency (must have)
• SAP (preferred)
• Quality/process exposure (preferred/ideal)
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