<p>Overview</p> <p>The Quality Manufacturing Engineer at Cook Incwill spend 50% of their time reviewing quality aspects of product lines, including: involvement in CAPA's, supplier quality and manufacturing The Quality Engineer serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.</p> <p>Responsibilities</p> <ul> <li>Performance of risk assessments, internal product and process non-conformances, quality investigations, independent projects and containment activities• Support/asses/develop continual improvement activities in response to non-conformances and other quality data metrics• Review/approve validations, test methods, protocols, monthly non-conformance reports, change requests, risk management files and other documents• Own or assist with internal investigations and CAPA's• Work with Quality Assurance and Production Engineering to verify/validate critical processes/products and apply control mechanisms around those processes/products so they can be effectively monitored• Trending of data and data analysis• Ensure compliance to quality system policies & department procedures• Maintain accurate timely reports and records </li></ul> <p>Qualifications</p> <ul> <li>Bachelor's degree in Engineering or related technical field; at least 5 years of experience in Quality Engineering, Manufacturing Engineering or Development Engineering• Knowledge of medical device regulations, pertinent standards and guidances• Knowledge of quality tools and principles </li><li>Experience in project management and managing multiple activities preferred </li></ul>