Quality Engineer

Yoh is hiring a Quality Engineer for our client. In this role, you will be responsible for supporting product and manufacturing quality through inspection and testing strategies, defect analysis, statistical analysis, documentation control, and continuous improvement initiatives. The Quality Engineer will work closely with Development, Product, Manufacturing, and Quality teams to ensure products and processes meet company, customer, and industry quality standards. This position requires strong analytical and problem-solving skills with the ability to identify quality issues, develop effective solutions, and drive improvements in a regulated environment.

Job Functions Review and thoroughly understand product functional and design specifications. Develop and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment. Conduct Quality Assurance testing to ensure products meet established requirements. Perform statistical analysis to evaluate products or materials that do not meet required standards and specifications. Conduct defect analysis utilizing statistical quality and process analytical methods. Prepare and maintain Quality reports and support documentation control systems. Review returned materials and verify customer complaints, developing action plans to address identified discrepancies. Communicate with customers regarding Quality issues and resolutions as required. Partner with operators and technicians to identify and resolve day-to-day Quality Assurance issues. Prioritize and manage multiple projects while working within design specifications and budget requirements. Maintain knowledge of evolving Quality Assurance codes, regulations, and industry standards. Document test cases and interpret technical and business objectives. Work closely with Development and Product teams to support Quality initiatives. Identify software bugs and support appropriate testing and resolution activities. Recommend changes and improvements to enhance overall product quality. Ensure products comply with company and applicable industry Quality standards. Develop and implement systems that promote conformity and accuracy throughout the production process. Collaborate with cross-functional teams to develop solutions for identified Quality and product issues. Perform additional duties as assigned by management. Education, Licensure and/or Experience Bachelor's degree in Engineering required; Master's degree in Engineering preferred. Professional certifications or 10+ years of equivalent work experience may be considered. Previous experience working in a Quality Assurance environment required. Knowledge of ISO 13485 and applicable EU standards. MDR experience is a plus. Knowledge of Quality Assurance and testing tools. Knowledge of SQL and scripting. Strong proficiency with Microsoft Office applications. Excellent analytical and problem-solving skills. Strong attention to detail with the ability to identify issues and develop effective solutions. Ability to work independently as well as collaboratively within a team environment. Strong written and verbal communication skills. Physical Job Requirements Full-time, onsite work environment. Regular use of a computer, keyboard, mouse, and other standard office and technical equipment. Ability to work within manufacturing, Quality, and product development environments as required. Must be able to review detailed technical documentation, specifications, test results, and Quality records for extended periods.