Product Quality Engineer II

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    "requisitionDescription": "<div>\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.49.19/styles/froala_editor.pkgd.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n    <link href=\"https://static.workforcenow.adp.com/mas/mdf-components/23.49.19/styles/froala_style.min.css\" rel=\"stylesheet\" type=\"text/css\" />\n\n    <div class=\"fr-view\">\n      <p id=\"isPasted\"><strong><u>Job Summary:</u></strong></p><p>The Product Quality Engineer II will be responsible for quality assurance activities including product quality engineering, non-conforming material report write ups and investigation, statistical process control, process improvements, and quality control oversight.</p><p>&nbsp;</p><p><strong><u>Essential Duties and Responsibilities:</u></strong></p><ul type=\"disc\"><li>Develop and maintain strong internal working relationships across restor3d.</li><li>Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.</li><li>Prioritize and plan work activities; adapt for changing conditions.</li><li>Assist in maintaining the quality system in accordance with applicable regulatory requirements.</li><li>Identify quality system process improvements and implement solutions.</li><li>Lead or assist with the Corrective Action/Preventive Action (CAPA) program.</li><li>Lead or assist with the Customer Complaint system by performing complaint investigations, including root cause analysis.</li><li>Assist with product inspections as needed.</li><li>Perform Internal Quality Audits of the quality system</li><li>Participate in supplier selection and approval process, including leading supplier audits and review of quality data.&nbsp;</li><li>Perform investigations of non-conformances and drive corrective actions.</li><li>Participate on cross-functional product development teams.</li><li>Participate in product/process validations.</li><li>Perform risk assessments, gathering cross-functional team input.</li><li>Employ statistical techniques and rationale in decision-making activities driven to support non-conformance trending, CAPA effectiveness, part qualification, and process monitoring.</li><li>Establish and trend quality metrics and data.</li><li>Participate in third party audits against ISO 13485 and FDA 21 CFR Part 820 requirements.</li><li>Other responsibilities as assigned.</li></ul><p>&nbsp;</p><p><strong><u>Qualifications:</u></strong></p><ul><li>Bachelor of Science in Engineering, Science, or Biomedical.&nbsp;</li><li>2+ years of Quality Assurance/Quality Engineering experience in the medical device industry and/or experience in an FDA regulated environment is required.</li><li>Knowledge of FDA 21 CFR Part 820 and ISO 13485, preferred.</li><li>ASQ certification (Certified Quality Engineer, Certified Quality Auditor, Certified Biomedical Auditor) a plus.</li></ul><p>&nbsp;</p><p><strong><u>Skills, Abilities, Competencies Required:</u></strong></p><ul type=\"disc\"><li>Excellent written and verbal communication skills.</li><li>Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.</li><li>Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.</li><li>Strong organizational, analytical, and time-management skills.</li><li>Able to self-motivate and work both independently and as part of a team.</li><li>Must have a solid knowledge of Microsoft office.</li><li>Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail.</li><li>Demonstrated proficiency with FDA and ISO standards for Medical Devices.</li></ul><p>&nbsp;</p><p><strong>restor3d is an Equal Opportunity Employer</strong></p>\n    </div>\n  </div>\n",
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