Quality Assurance Engineer

What You’ll Do

• Develop and maintain quality assurance processes that ensure products consistently meet customer and regulatory requirements

• Partner with engineering, manufacturing, and supply chain teams to embed quality into every stage of production

• Create inspection plans, test protocols, and validation procedures to support new product launches

• Lead investigations into quality issues using root cause analysis and drive corrective/preventive actions (CAPA)

• Monitor and audit processes, products, and suppliers to verify compliance with quality standards

• Track key quality metrics and use data analysis to identify trends and recommend improvements

• Support training programs that promote quality awareness and proper documentation practices across the organization

• Ensure incoming materials, in-process products, and finished goods align with specifications and standards

• Champion continuous improvement efforts to increase reliability, consistency, and efficiency

What We’re Looking For

• Bachelor’s degree in Quality, Mechanical, Manufacturing, or Industrial Engineering (or related field)

• 3+ years of experience in quality assurance or quality engineering (medical device or precision manufacturing preferred)

• Strong knowledge of quality management systems (ISO 13485, ISO 9001, or equivalent)

• Familiarity with FDA regulations and medical device compliance requirements a plus

• Hands-on experience with root cause analysis, FMEA, SPC, and CAPA methodologies

• Solid understanding of inspection methods, GD&T, and measurement systems

• Proficiency with ERP/MRP systems, quality software, and data analysis tools

• Strong communication skills and the ability to work effectively with cross-functional teams