Quality Systems Engineer

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    "description": "<p><span style=\"font-size:12.0pt\"><span style=\"font-family:&quot;Cambria&quot;,serif\">The Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company&rsquo;s goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness.</span></span></p>\r\n\r\n<p>&nbsp;</p>\r\n\r\n<ul>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Act as a role model and ensure safety is built into our QMS and work processes.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Ensure compliance with ISO 13485 and 21 CFR Part 820 by providing regulatory guidance, conducting gap analyses, and leading corrective actions to close compliance gaps.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Design and improve quality assurance and control procedures, continuously optimizing the QMS to enhance regulatory compliance.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Investigate and resolve non-conformances, implementing corrective and preventive actions (CAPA) to mitigate risks and improve product quality.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Lead or participate in internal audits, identifying gaps and implementing necessary improvements to maintain audit readiness.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Apply problem-solving methodologies to prioritize and resolve quality issues promptly.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Utilize Six Sigma and other quality tools to reduce process variation and enhance product quality.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Monitor quality data and trends, providing recommendations to reduce defects and improve quality performance.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Provide training to employees on quality system requirements to ensure compliance and consistency across departments.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Collaborate with cross-functional teams to drive continuous improvements and optimize the effectiveness of the QMS.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Assist in preparing for and supporting external audits, inspections, and regulatory assessments, ensuring that the company remains audit ready.</span></span></li>\r\n\t<li><span style=\"font-size:12pt\"><span style=\"font-family:Cambria,serif\">Drive quality system enhancements, identifying and implementing improvement opportunities across the organization.</span></span></li>\r\n\t<li><span style=\"font-size:12.0pt\"><span style=\"font-family:&quot;Cambria&quot;,serif\">Other duties as required. </span></span></li>\r\n</ul>\r\n",
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