Entry-level Quality Engineer responsible for maintaining ISO 13485 and ISO 9001 quality systems, supporting audits, new product introduction, process validation, testing, corrective actions, and continuous improvement. The role analyzes product and process data, develops control plans and inspection methods, troubleshoots manufacturing issues, supports equipment qualification, and collaborates with production, customers, suppliers, and cross-functional teams. Polymer materials knowledge, statistical analysis, laboratory practices, and proficiency with Minitab or R are required.