<p>JOB SUMMARY:</p> <p>Leads the efforts to identify, investigate, plan, and conduct activities to improve or ensure quality through design and manufacturing of medical devices and components. Leads cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components. Will act as the subject matter expert (SME) on elements within the quality department.</p> <p>ESSENTIAL/PRIMARY DUTIES:</p> <ul> <li>Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.). </li><li>Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies. </li><li>Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain. </li><li>Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk. </li><li>Formulates solutions to complex and ambiguous problems that are not well defined. Incorporates feedback and solutions from others. </li><li>Communicates complex technical ideas through daily work, presentations, and workshops. </li><li>Fosters cross team communication and knowledge sharing. Collaborates with teams and management to make critical technical decisions that align with organizational goals. </li><li>Collaborates with leadership and other cross functional departments to align decisions with organizational goals. </li><li>Champions six sigma techniques and drives standardization through continuous process improvement. </li></ul> <p>SECONDARY DUTIES:</p> <ul> <li>Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers. </li><li>Provides leadership, coaching, and/or mentoring to the co-op group and level I, II & III engineers. </li><li>Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations. </li><li>Teaches and provides guidance on engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records. </li></ul> <p>EDUCATION and/or EXPERIENCE:</p> <p>Bachelor's degree in engineering or related field and 6+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.</p> <p>COMPETENCY and/or SKILL:</p> <ul> <li>Experience in the medical device industry and understanding of medical device quality systems and applications is desired </li><li>Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives </li><li>Ability to establish and enforce quality standards that align with industry best practices and regulatory requirements </li><li>Expert problem solver in areas of expertise </li><li>Ability to lead the design of complex, interconnected systems or processes and shape the organization's technical direction </li></ul> <p>SUPERVISORY RESPONSIBILITIES:</p> <ul> <li>Provides leadership, coaching, and/or mentoring to level I, II and level III engineers. </li><li>May have direct reports of technicians or level I & level II engineers. </li></ul>