R+D Quality Engineer III

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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;\">The R + D Quality Engineer III leads and enforces product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design and manufacturability of medical devices.</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;\">Plans, leads, and manages quality deliverables on new product development (NPD) projects in accordance with regulatory standards ISO9001:2015, ISO13485:2016, ISO14971, FDA, CSA, and EU MDR regulations.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Leads all risk management processes and creates risk management documentation for (NPD) projects.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Creates, reviews, and approves documentation related to the engineering Product Realization Process (PRP). Documentation includes, but is not limited to, change requests, engineering orders, product and component test specifications and design records.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Facilitates 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;\">Leads site-based quality department initiatives as a subject matter expert (SME).</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Applies domain expertise to the application and advancement of engineering methods and tools. Leads the application of six sigma techniques and drives continuous process improvement.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Collaborates with cross-functional teams to align decisions with business goals.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Mentors engineer I &amp; II teammates, focusing on technical skills, collaboration skills, and cultural competencies.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Applies advanced tools and methods to solve complex problems. Tackles technical challenges and contributes to troubleshooting effort.</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;\">Supports internal and external quality system audits.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Leads the creation of threat models and cybersecurity risk assessments.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Leads the creation and maintenance of the products Usability Engineering Files, provides misuse cases involving use error and assesses the impact.</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Assists with the creation of the reliability predictions for projects with recommended testing profiles and analyzes test results.</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 4+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt (DMAIC, DMADV), and Certified Reliability Engineer (CRE) certifications 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:</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;\">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 apply advanced analytical tools and methods to solve complex problems</span></li><li><span style=\"font-family:&quot;Century Gothic&quot;,sans-serif;font-size:10.0pt;\">Ability to lead the design of complex systems and identify new technological opportunities</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 and level II engineers.</span></li></ul>",
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