Advanced Quality Engineer

Overview

Advanced Quality Engineer

• 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.

Bachelor s Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent/ Vocational Education.

• 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

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Learn more about our rich and exciting history.

Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities rn more about our culture of impact with care here.