<p>JOB SUMMARY:</p> <p>This role involves maintaining and improving quality engineering methodologies. This role requires more experience in supplier audits, quality improvement plans, and problem-solving. A deeper understanding of medical device manufacturing and quality systems is required. Can perform duties without supervision.</p> <p>ESSENTIAL/PRIMARY DUTIES:</p> <ul> <li>Conducts activities concerned with the quality assurance of a given commodity set by working closely with suppliers, manufacturing, purchasing, and supplier quality. </li><li>Analyzes processes and contributes to improvements. </li><li>Collaborates with cross functional/development teams to address quality concerns, drive improvements, and take ownership of technical solutions and their outcomes. </li><li>Assists in the review and approval of supplier corrective action plans and assists in the investigation of any supplier-related complaints. </li><li>Identifies and communicates risks, participates in issue resolution, and mentors junior engineers. </li><li>Assists in identifying/evaluating risks and contributes to risk mitigation. </li><li>Participate in new product development teams and component qualification process as needed to carry out approvals for given components. </li><li>Conducts and documents regular visits/audits to assigned suppliers to review manufacturing processes, quality systems/controls, pre-launch readiness, root cause identification, corrective actions, and process improvement opportunities. </li><li>Has a commodity focus that is mixed between custom engineered components and distributed/off the shelf components and OEM products and actively works with Global Sourcing in new supplier selection and qualification. </li><li>Applies advanced engineering methods and tools to solve engineering problems. Identifies and contributes to process improvements utilizing six sigma techniques. May assist six sigma training at suppliers. </li></ul> <p>SECONDARY DUTIES:</p> <ul> <li>Assists in developing and maintaining supplier quality improvement programs and metrics. </li><li>Participates in either back room or front room in support of MDSAP (or equiv.) audits. </li><li>Assists in internal audits. </li></ul> <p>EDUCATION and/or EXPERIENCE:</p> <p>Bachelor's degree in engineering or related field and 2+ years of relevant experience, or equivalent experience. Six Sigma Black Belt certification will be required in the role.</p> <p>COMPETENCY and/or SKILL:</p> <ul> <li>Effective communication with both internal and external stakeholders </li><li>Working knowledge of FDA CFR 820 and ISO 13485 </li><li>Advanced analytical skills, ability to define and analyze complex problems </li></ul> <p>SUPERVISORY RESPONSIBILITIES:</p> <ul> <li>Provides leadership, coaching, and/or mentoring to co-op's and engineer I's. </li></ul>