Sr Quality Engineer

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    "requisitionDescription": "<div>\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/22.3.26/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <p id=\"isPasted\"><strong><u>SUMMARY/RESPONSIBILITIES:&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</u></strong></p><p><strong>&nbsp;</strong></p><p>This position provides Quality Engineering support in the development, manufacture, and distribution of Imperative Care&rsquo;s medical device products consistent with the Company&rsquo;s Quality Policy and Quality Objectives. &nbsp;</p><p><strong>&nbsp;</strong></p><p><strong>ESSENTIAL DUTIES AND RESPONSIBILITIES&nbsp;</strong>include the following. &nbsp; &nbsp;Other duties may be assigned on an individual basis:</p><ul><li>Responsible for Quality input to define required validations necessary to support significant process changes on commercially launched products.&nbsp;</li><li>Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities.</li><li>Analyse data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored. &nbsp;</li><li>Create and revise quality assurance procedures as required to maintain compliance to changing regulations and guidance documents. &nbsp;</li><li>Lead training on the use of procedures to promote compliance with Quality System and Regulations to a broad audience.</li><li>Liaison with laboratories to conduct routine product testing or root cause analysis related to testing failures or deviations.&nbsp;</li><li>Conduct methodical root cause investigations and provide guidance on actions necessary to prevent recurrence.</li><li>Direct interaction with suppliers to qualify and maintain approved supplier status. &nbsp;May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance. &nbsp; &nbsp;</li><li>Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation&nbsp;</li><li>Review DCO&rsquo;s involving product or process changes to ensure consistency with company procedures and quality system compliance.&nbsp;</li><li>Conduct and review Risk Management assessments on product and process changes.</li><li>Conduct failure mode effect analysis on product&nbsp;</li><li>Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives. &nbsp;</li></ul><ul type=\"disc\"><li>Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/MDD regulations.</li><li>May provide quality metric data to various functional groups within the organization.&nbsp;</li><li>Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.</li><li>Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.&nbsp;</li><li>Actively promote and support the company&rsquo;s Management Review process. &nbsp;</li><li>Inform responsible personnel of concerns involving product quality.</li><li>Perform job functions in a safe and effective manner.</li><li>Other duties as assigned</li></ul><p>&nbsp;</p><p><strong><u>EDUCATION/EXPERIENCE:&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;</u></strong></p><p>&nbsp;</p><ul><li>BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry&nbsp;Experience with development and validation of test methods to comply with recognized standards</li><li>Experience working with catheters, endovascular or neurological devices highly desired</li><li>Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)</li><li>Must be knowledgeable about quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</li><li>Excellent communications skills (both written and verbal)</li><li>Must be able to provide thorough and meticulous review of documents</li><li>Must be able to write clear, concise, and well thought out technical documentation with a focus on failure investigations and inspection procedures</li><li>Must be able to perform multiple tasks concurrently with accuracy</li><li>Proficiency with Microsoft Office products</li></ul>\n    </div>\n  </div>\n",
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