Principal Engineer, Supplier Quality

Location:   Nakorn Pathom, Thailand (5 days' work week based at manufacturing site) T ype of medical device portfolio: Safe Saf Access Infusion set, Suction tubing, Drainage bag, Enteral feeding, Connecting tube. Type of raw materials: PVC resin, Component, Packaging. Reporting to:   Manager, Quality Management (based onsite) THE COMPANY and BUSINESS Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals and specialty products; a global manufacturer and distributor of medical and laboratory products; an operator of nuclear pharmacies and manufacturing facilities; and a provider of performance and data solutions. Working to be healthcare’s most trusted partner, our customer-centric focus drives continuous improvement and leads to innovative solutions that improve the lives of people every day.

Leading/Support improvements to quality and resolution of daily quality issues that result in reduced quality issues. Using a systematic approach to managing quality improvements and resolution of daily quality issues. Support product and process validations. Support the development and design transfer of new products using Advanced Quality Planning. Driving continuous improvement activities for product related quality in production floor.

Quality Engineering is responsible for raw material and service quality planning, evaluation, and control. Identifies supplier risk levels and completes supplier qualification requirements with related records. Reviews the process to qualify raw materials and components used in Finished Good Products with cross-functional teams to ensure information is adequate for all requirements and expectations. Partners with suppliers to manage supplier performance. Works cross-functionally internally and suppliers in the development and implementation of prevention-based methodologies used in manufacturers, test, providing data. Demonstrates strong understanding of quality principles, systems, methods, tools, and standards. Develop and implement quality programs, including tracking, analyzing, reporting and problem solving. Plans, controls, and assures raw material and process quality in accordance with quality requirements. Demonstrates knowledge of reliability, maintainability, and risk management. Apply problem solving and quality improvement tools and techniques, including preventative and corrective actions and how to overcome barriers to quality improvements. Acquires and analyzes data using appropriate standard quantitative methods to facilitate process analysis and improvements. Ongoing monitoring and drive quality performance in production processes to meet quality goals. Ensure compliance of QMS and identify the issue and follow up through CAPA Process. Support risk analysis and risk management as required. Using a systematic approach to managing quality improvements and resolution of daily quality issues. Support product and process validations. Support the QMS audit process. Performs other related duties of similar type and work on assigned. Emphasize company environment health and safety rules and regulations to employees and ensure compliance. Qualifications & Experience Bachelor’s degree in Science or Engineering (Quality Engineering background preferred). At least 4 years’ experience in quality improvement related field. experience with ISO 13485 or equivalent quality management standards as a preferred qualification ​ Familiar with quality principles, methods, tools for problem solving and quality improvement programs, FMEA which may include but not limited to tracking, analyzing, reporting and tools and techniques. Familiar with statistical analysis tools for data analysis. Computer literacy in Microsoft Word, PowerPoint and Excel. Expert in Excel i.e. graphs, Power BI, VLOOKUP etc. A comprehensive understanding of quality processes, manufacturing operations and control procedures within manufacturing operations