Quality Assurance Engineer

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

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