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

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

Apply to Quality Assurance Engineer