Senior Quality Engineer

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    "ExternalDescriptionStr": "<p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>JOB SUMMARY:</strong></span></p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">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.</span></p><p>&nbsp;</p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>ESSENTIAL/PRIMARY DUTIES:</strong></span></p><ul><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Formulates solutions to complex and ambiguous problems that are not well defined. Incorporates feedback and solutions from others.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Communicates complex technical ideas through daily work, presentations, and workshops.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Fosters cross team communication and knowledge sharing. Collaborates with teams and management to make critical technical decisions that align with organizational goals.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Collaborates with leadership and other cross functional departments to align decisions with organizational goals.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Champions six sigma techniques and drives standardization through continuous process improvement.</span></li></ul><p>&nbsp;</p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>SECONDARY DUTIES:</strong></span></p><ul><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Provides leadership, coaching, and/or mentoring to the co-op group and level I, II &amp; III engineers.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Teaches and provides guidance on engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.</span></li></ul><p>&nbsp;</p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>EDUCATION and/or EXPERIENCE:</strong></span></p><p><span style=\"background-color:white;color:black;font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">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.</span></p><p>&nbsp;</p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>COMPETENCY and/or SKILL:&nbsp;</strong></span></p><ul><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Experience in the medical device industry and understanding of medical device quality systems and applications is desired</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to establish and enforce quality standards that align with industry best practices and regulatory requirements</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Expert problem solver in areas of expertise</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to lead the design of complex, interconnected systems or processes and shape the organization's technical direction</span></li></ul><p>&nbsp;</p><p><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\"><strong>SUPERVISORY RESPONSIBILITIES:</strong></span></p><ul><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Provides leadership, coaching, and/or mentoring to level I, II and level III engineers.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">May have direct reports of technicians or level I &amp; level II engineers.</span></li></ul>",
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