Senior Quality Systems Engineer at Access Vascular, Inc.

<p><strong>Job Descriptions:</strong></p> <p>Manage the Access Vascular Inc (AVI) Quality Management System for a growing start-up company that designs, manufactures, and distributes sterile catheter-, software-, electromechanical-based medical device product families. Provide Quality Engineering support for Operations and Operations Quality projects and tasks.&nbsp;</p> <p>This is a key contributor position working closely among the AVI team with AVI’s QMS and FDA QMSR requirements.</p> <p><strong>Responsibilities:</strong></p> <p><strong>Quality Management System</strong></p> <p><strong>• &nbsp; </strong>&nbsp;Own, maintain, and continuously improve the company's QMSR and ISO 13485-compliant QMS<br>• &nbsp; &nbsp;Drive continuous improvement to company SOPs, work instructions, forms, test protocols, infrastructure software and other controlled documents<br>• &nbsp; &nbsp;Manage document control and records management in compliance with 21 CFR Part 820<br>• &nbsp; &nbsp;Lead internal audits and support external audits (FDA, Supplier)<br>• &nbsp; &nbsp;Lead CAPA investigations to root cause, ensuring timely closure and effectiveness verification<br>• &nbsp; &nbsp;Develop and communicate quality metrics and data analysis to inform continuous improvement and risk-based decision making<br>• &nbsp; &nbsp;Lead statistical methods development for quality metrics, inspection planning, and continuous improvement initiatives<strong><br></strong></p> <p><strong>Operations &amp; Supplier Quality</strong></p> <p>• &nbsp; &nbsp;Collaborate with Operations to ensure manufacturing processes are controlled and validated<br>• &nbsp; &nbsp;Act a subject matter expert (SME) for risk management, sterilization validation, and data integrity and how it defines validation, verification, and inspection sampling rigor<br>• &nbsp; &nbsp;Support incoming inspection, nonconforming material control, and disposition activities<br>• &nbsp; &nbsp;Provide Quality Engineering support to infrastructure move and expansion projects<br>• &nbsp; &nbsp;Manage supplier qualification, evaluation, and monitoring programs<br>• &nbsp; &nbsp;Conduct supplier audits and review supplier corrective action responses<strong><br></strong></p> <p><strong>Post-Market Surveillance&nbsp;</strong></p> <p>• &nbsp; &nbsp;Manage complaint handling, MDR reporting processes, and trend analysis<br>• &nbsp; &nbsp;Maintain knowledge of applicable standards and regulations and communicate updates to the team<br>• &nbsp; &nbsp;Assist in preparation for and response to FDA inspections and Notified Body audits<strong><br></strong></p> <p><strong>Leadership &amp; Culture</strong></p> <p>• &nbsp; &nbsp;Champion a proactive quality culture across a small, multidisciplinary team<br>• &nbsp; &nbsp;Provide quality training and mentoring to engineering, operations, and management staff<strong><br></strong></p> <p><strong>Qualifications:</strong></p> <p>• &nbsp; &nbsp;Bachelor's degree in Engineering, Life Sciences, or a related technical field<br>• &nbsp; &nbsp;Minimum of 5 years’ of quality systems experience with a medical device manufacturing company<br>• &nbsp; &nbsp;Proven track record with implementing, evolving, and improving medical device company quality management systems (QMS) compliant to FDA 21 CFR Part 820, ISO 13485:2016, and ISO 14971<br>• &nbsp; &nbsp;Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality<br>• &nbsp; &nbsp;Strong technical writing skills with the ability to produce clear, compliant documentation<br>• &nbsp; &nbsp;Experience with statistical techniques, sampling plans, and data analysis for validation and process capability<br>• &nbsp; &nbsp;Highly organized, self-directed, and comfortable in a fast-paced environment<br>• &nbsp; &nbsp;ASQ Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus<br>• &nbsp; &nbsp;Lead auditor certification (ISO 13485 or equivalent) is a plus<br>• &nbsp; &nbsp;Experience with implementing and validating eQMS platforms (e.g., Greenlight Guru, MasterControl, ETQ) is a plus<br>• &nbsp; &nbsp;Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus<br>• &nbsp; &nbsp;Experience supporting 510(k) submissions or technical files for CE marking is a plus<br>• &nbsp; &nbsp;Prior experience at a startup or early-stage medical device company is a plus<strong><br></strong></p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Compensation Commensurate With Experience</div><div class="pay-range"><span>$93,000</span><span class="divider">&mdash;</span><span>$160,000 USD</span></div></div></div><div class="content-conclusion"><h1>About Access Vascular</h1> <p><a href="https://www.accessvascularinc.com/">Access Vascular</a> was founded in 2015 to address the most common and costly complications of intravenous therapy: infection, thrombosis and phlebitis. The company is developing a suite of venous access devices made from patented biomaterials which are highly biocompatible and have demonstrated 6X fewer complications. .</p></div>