Senior Specialist, Quality Assurance and Regulatory Compliance

<div><div><p><b><span>In this role, you will have the </span><span>op</span><span>portunity to: </span></b><span> </span></p></div><div><ul><li><p><span><span>Lead technical complaint investigations with cross-functional teams, including analyzing complex customer complaint data</span><span> to identify potential root cause trends and present to cross-functional audiences, including sales, marketing &amp; engineering personnel</span><span>;</span><span> </span><span>applying principles of risk management in accordance with ISO 14971 in order to prioritize the criticality of customer complaints and to determine MDR reportability</span><span>;</span><span> and monitoring and improving tracking/control systems for complaint handling and MDR reporting using Microsoft Excel or other software applications</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Collaborate with Quality Control and Research and Development personnel on physical evaluation of returned complaint product, ensuring sound scientific experimental planning and recommending applicable statistical sample sizes </span><span>in accordance with</span><span> industry standards; approve technical scientific reports for complaint investigations</span></span><span> </span></p></li></ul></div></div><div><div><ul><li><p><span><span>Lead the investigations for the highest risk complaints and perform the regulatory reporting as </span><span>required</span><span> globally (for example, MDRs, MIRs, etc.)</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Provide </span><span>a high level</span><span> of subject matter </span><span>expertise</span><span> to the organization in regulatory reporting guidance</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Participate in</span><span> performance and documentation of internal and external audits </span><span>in accordance with</span><span> internal and supplier auditing schedules, respond to audit findings by proposing and implementing necessary corrective actions, and </span><span>support</span><span> Field Corrective Action responses via data compilation </span><span>and</span><span> customer follow-up</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><b><span>The essential requirements of the job include:</span></b><b><span> </span></b><span> </span></p></div><div><ul><li><p><span><span>Bachelor’s degree in science, engineering, medical or technical field</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proven experience </span><span>in </span><span>technical quality role</span><span>s </span><span>with increasing responsibility</span><span> in medical device manufacturing</span><span>, </span><span>leading root cause investigations and structured problem solving using CAPA’s</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proficiency</span><span> using Microsoft Office, including Word, Excel, and PowerPoint</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proficiency</span><span> in English</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Strong interpersonal, </span><span>written</span><span> and oral communications skills, </span><span>including ability to </span><span>explain complex information to others</span><span>,</span><span> influence change outside of the local span of control</span><span>, </span><span>and </span><span>build consensus with other departments and project teams</span></span><span> </span></p></li></ul></div></div><p>Travel %<i> of Travel, include approximate overnight stays per week</i></p><ul><li>Travel expectations for this role is limited and mainly flexible (10%)</li></ul><p></p><p>Location: </p><ul><li><span><span>This </span><span>is part of the Global Post Market Surveillance team </span><span>located</span><span> in Shanghai, China and will be an on-site role.</span></span><span> </span></li></ul><p></p><p>Reporting to:</p><p><span><span>This position reports to the </span><span>Director, Post Market Surveillance</span></span></p><p><span>Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.</span></p><p></p><p><span>For more information, visit </span><a href="http://www.danaher.com/" target="_blank"><span>www.danaher.com</span></a><span>.</span></p>