The Quality Assurance Manager oversees setting and maintaining quality standards for in-process and finished products, developing testing, sampling, and training methods. They evaluate production processes, recommend improvements, qualify vendors, and manage documentation such as product specs and technical files. Responsibilities include implementing process control and validation methods, designing experiments, analyzing data with statistical tools, collaborating with suppliers on quality issues, and ensuring regulatory compliance. They lead investigations into non-conformances, develop CAPAs, and may train team members. Requirements include a bachelor’s degree in a related field, at least 4 years of QA or engineering experience, knowledge of industry standards, and strong problem-solving skills. Preferred qualifications include 5+ years in medical device or related fields and Six Sigma/Lean expertise. The role offers competitive compensation, benefits, and up to 15% travel.