Senior Quality Manufacturing Engineer

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    "description": "<h2>Overview</h2>\n<p>The Quality Engineer serves as the lead quality representative of certain product lines within manufacturing.</p>\n<h2>Responsibilities</h2>\n<p>- Perform work per external and internal quality standards.- Interface with internal and external groups on quality-related issues.- Support product development and transfer to manufacturing.- Facilitate development and implementation of production controls. (e.g. qualification, process capability, sampling plans, validation, etc.)- Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues.- Plan, review, and approve change requests.- Execute risk assessment as needed and facilitate development and completion of risk file documentation.- Conduct Risk-based decision making and effective resolution of issues.- Lead or support CAPAs as necessary. - May interface with internal or 3rd party audits. (e.g. FDA, Notified Body, etc.)- Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.- Provide leadership in the understanding of medical device regulations and best practices.- Manage conflict resolution as it relates to technical situations.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.</p>\n<p>Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.</p>\n<h2>Qualifications</h2>\n<p>- Engineer degree and 5-8 years of experience- Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)- Professional certification (e.g. ASQ, Six Sigma, etc.) preferred.- Proficiency in statistical, quality and continuous improvement methods and tools.- Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.- Strong organizational skills.- Critical thinking and attention to detail required.- Excellent verbal communication skills and technical writing.</p>",
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