Quality Engineer

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    "description": "<p>ROMTech is a medical technology company that has created and patented a revolutionary medical device and telemedical platform which delivers in-home rehabilitative care. Our disruptive technology has proven to yield faster recoveries and better outcomes with unmatched patient compliance. We began in orthopedics and have entered scale-up of our orthopedic business. We are now leveraging our core technology, infrastructure, and first mover position to enter cardiology, followed by other adjacent markets. Having created this new lane, we have a unique opportunity to serve as the global leader in the business, technology, and science of recovery, and to bring life-changing help to many millions of people.</p>\r\n\r\n<p><strong>Job Summary:</strong></p>\r\n\r\n<p>The&nbsp;Quality Engineer&nbsp;position reports directly to the Director of Quality.&nbsp;The&nbsp;Quality&nbsp;supports the execution of the&nbsp;design and development&nbsp;for&nbsp;new products and supports sustaining activities for existing legacy products.&nbsp;&nbsp;&nbsp;</p>\r\n\r\n<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{14}\" paraid=\"546332556\" xml:lang=\"EN-US\"><strong>Duties &amp; Responsibilities:&nbsp;&nbsp;</strong></p>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{19}\" paraid=\"1898309161\" xml:lang=\"EN-US\">Design and review project documentation, ensuring alignment with defined user needs, intended use, and indications for use,&nbsp;participating&nbsp;in product risk assessments, and working closely with Development to develop&nbsp;appropriate risk-based&nbsp;verification and validation testing requirements.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"2\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{34}\" paraid=\"1234977581\" xml:lang=\"EN-US\">Other responsibilities as assigned&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"3\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{41}\" paraid=\"13942124\" xml:lang=\"EN-US\">Support evaluation of complaints and adverse events for MDR (Medical Device Reporting) requirements, ensuring&nbsp;timely&nbsp;escalation and regulatory compliance.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"4\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{48}\" paraid=\"696854626\" xml:lang=\"EN-US\">Review nonconforming material (NCRs) for design impact and ensure proper linkage to design changes, risk, and CAPA, and support alignment of DMR/DHR to ensure consistency between design and fielded devices.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"5\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{55}\" paraid=\"1796696682\" xml:lang=\"EN-US\">Ensure traceability of devices and configurations.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"6\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{62}\" paraid=\"808834756\" xml:lang=\"EN-US\">Communicate regularly with Manufacturing and Test counterparts, and proactively engage in issue resolution across design, manufacturing, and field operations, ensuring alignment between designed, built, and fielded product configurations.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"7\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{69}\" paraid=\"1116203870\" xml:lang=\"EN-US\">Ability to&nbsp;participate&nbsp;in gathering of QA Engineering&nbsp;metrics&nbsp;gathering and compiling for higher level review, including design quality, field performance, and reliability metrics.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"8\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{76}\" paraid=\"523211560\" xml:lang=\"EN-US\">Support analysis of product reliability and performance, including failure trends, repair data, and time-to-failure, and collaborate with engineering to drive design improvements.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"9\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{83}\" paraid=\"1452719115\" xml:lang=\"EN-US\">Audit, monitor, and witness test processes for compliance with requirements and keeping a watchful eye for risk opportunities, ensuring test coverage is complete and reflects intended use and real-world conditions.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"10\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{90}\" paraid=\"621542628\" xml:lang=\"EN-US\">Participate in and&nbsp;maintain&nbsp;risk management activities, ensuring risks are&nbsp;identified, updated, and controlled based on design changes, testing results, and post-market data.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"11\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{97}\" paraid=\"886986805\" xml:lang=\"EN-US\">Ensure all design changes, upgrades, and&nbsp;component&nbsp;substitutions are evaluated through formal design control processes, including impact assessment, verification/validation, and approval, and prevent uncontrolled changes during manufacturing or refurbishment activities.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"12\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{104}\" paraid=\"1021150250\" xml:lang=\"EN-US\">Support and ensure software and hardware design control, including&nbsp;requirements&nbsp;traceability, configuration management, and alignment between design outputs and released product configurations.&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"13\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{3a556787-3032-4380-ad22-5e70e5457813}{111}\" paraid=\"1388263975\" xml:lang=\"EN-US\">Work with the Design, Development Engineering, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs, and field feedback including refurbishment data, complaints, and performance trends.&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<p>&nbsp;</p>\r\n",
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and&nbsp;component&nbsp;substitutions are evaluated through formal design control processes, including impact assessment, verification/validation, and approval, and prevent uncontrolled changes during manufacturing or refurbishment activities.&nbsp;&nbsp;\\r\\n\\t\\r\\n\\r\\n\\r\\n\\r\\n\\t\\r\\n\\tSupport and ensure software and hardware design control, including&nbsp;requirements&nbsp;traceability, configuration management, and alignment between design outputs and released product configurations.&nbsp;&nbsp;\\r\\n\\t\\r\\n\\r\\n\\r\\n\\r\\n\\t\\r\\n\\tWork with the Design, Development Engineering, Regulatory Affairs, Quality, and other cross-functional partners to clarify design intent, identify critical features, and assess feature risk to implement the quality/reliability objectives for each component using knowledge of past performance, use conditions, therapy performance and product function, user needs, and field feedback including refurbishment data, complaints, and performance 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    "qualifications": "<p><strong>Skills and Abilities:&nbsp;</strong></p>\r\n\r\n<p>&nbsp;</p>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{35}\" paraid=\"737691308\" xml:lang=\"EN-US\">Multi-tasking, prioritization&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{50}\" paraid=\"760731981\" xml:lang=\"EN-US\">Technical writing ability at a level sufficient to complete&nbsp;Design History File documentation (test protocols, test reports).&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{66}\" paraid=\"882982250\" xml:lang=\"EN-US\">Strong aptitude with spreadsheet&nbsp;utilization&nbsp;(pivot tables, data&nbsp;analysis&nbsp;and reporting)&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{82}\" paraid=\"1243157106\" xml:lang=\"EN-US\">Problem-solving, assertiveness&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{98}\" paraid=\"2080087825\" xml:lang=\"EN-US\">Ability to thrive in a&nbsp;fast-paced&nbsp;environment &nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{114}\" paraid=\"612383040\" xml:lang=\"EN-US\">Excellent interpersonal and communication skills&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{114}\" paraid=\"612383040\" xml:lang=\"EN-US\"><strong>Work Experience Requirements:&nbsp;</strong></p>\r\n\r\n<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{114}\" paraid=\"612383040\" xml:lang=\"EN-US\">&nbsp;</p>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{213}\" paraid=\"1533219390\" xml:lang=\"EN-US\">Minimum Experience: 8+ years of experience in&nbsp;Medical Device Industry &nbsp;&nbsp;</p>\r\n\t</li>\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{213}\" paraid=\"1533219390\" xml:lang=\"EN-US\">B.S. degree in Engineering, Math, Physical Science, or equivalent field &nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{228}\" paraid=\"1966879100\" xml:lang=\"EN-US\">Strong&nbsp;knowledge of&nbsp;21 CFR Part 820 (CGMP) &nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{20359252-219b-499f-a421-77524e4ea88a}{244}\" paraid=\"2112408410\" xml:lang=\"EN-US\">Strong knowledge of quality management systems and manufacturing processes&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" data-aria-level=\"1\" data-aria-posinset=\"1\" data-font=\"Symbol\" data-leveltext=\"\" data-list-defn-props=\"{\">\r\n\t<p lang=\"EN-US\" paraeid=\"{85197a8e-556b-477d-821b-b048f25483ec}{5}\" paraid=\"1876241246\" xml:lang=\"EN-US\">Strong experience with risk management (ISO 14971)&nbsp;&nbsp;</p>\r\n\t</li>\r\n</ul>\r\n\r\n<ul role=\"list\">\r\n\t<li 335552541=\"\" aria-setsize=\"-1\" 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