Quality Engineer II

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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;\">Identifies, investigates, plans, and conducts activities to improve or ensure quality through design and manufacturing of medical devices and components. Cross-functionally collaborates with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components.</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;\">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;\">Identifies testing and validation opportunities, contributes to product and process improvements.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Works on moderately complex projects, generates alternatives, and conducts testing.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Applies new tools and identifies opportunities for improvements using six sigma methods.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Conducts the design and process failure mode and effects analysis (FMEA) process.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Participates in Design Control Process (including design input, design output, reviews, qualifications, validations, etc.).</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Identifies and communicates risks, participates in issue resolution, mentors junior engineers.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Applies advanced engineering methods and tools to solve engineering problems.</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;\">Provides leadership, coaching, and/or mentoring to the co-op group and level I engineers.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Supports 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;\">Understands engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Follows industry standards and regulations for quality, safety, and performance.</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=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Bachelor's degree in engineering or related field and 2+ years of relevant experience, or similar combination of both. Six Sigma Greenbelt certification is 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;\">Fully understand basic engineering tools and methods</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Mastery of software programs - Microsoft Word, PowerPoint, Excel, Project, Minitab</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Strong written and verbal communication skills</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to contribute ideas for process changes and improvements</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to define and analyze complex problems</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to generate alternatives and take reasonable risks to solve technical problems</span></li></ul><p style=\"margin-left:0in;\">&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 engineers and co-op's.</span></li></ul>",
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