Senior/Principal Quality Systems Engineer at Access Vascular, Inc.

<p>&nbsp;</p> <p>Access Vascular designs, manufactures, and distributes sterile catheter-based, software-enabled, and electromechanical medical devices. This role helps oversee our Quality Management System and provides Quality Engineering support across Operations, working closely with a small, hands-on team under AVI's QMS and FDA QMSR requirements.</p> <p><strong>Quality Management System</strong></p> <ul> <li>Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS</li> <li>Support improvements to SOPs, work instructions, forms, test protocols, and other controlled documents</li> <li>Support document control and records management under 21 CFR Part 820</li> <li>Participate in internal audits and support external audits (FDA, supplier)</li> <li>Lead or support CAPA investigations — root cause analysis, timely closure, effectiveness verification</li> <li>Help develop quality metrics and data analysis to guide risk-based decisions</li> </ul> <p><strong>Operations &amp; Supplier Quality</strong></p> <ul> <li>Partner with Operations to help ensure manufacturing processes are controlled and validated</li> <li>Contribute to risk management, sterilization validation, and data integrity practices</li> <li>Support incoming inspection, nonconforming material control, and disposition</li> <li>Provide Quality Engineering input on infrastructure and expansion projects</li> <li>Support supplier qualification, evaluation, and monitoring</li> <li>Help conduct supplier audits and review corrective action responses</li> </ul> <p><strong>Post-Market Surveillance</strong></p> <ul> <li>Support complaint handling, MDR reporting, and trend analysis</li> <li>Stay current on relevant standards and regulations and help keep the team informed</li> <li>Assist with preparation for FDA inspections and Notified Body audits</li> </ul> <p><strong>Leadership &amp; Culture</strong></p> <ul> <li>Help champion a proactive quality culture across a small, multidisciplinary team</li> <li>Offer quality training and mentoring where you can — we all wear a few hats here!</li> </ul> <hr> <p><strong>Qualifications</strong></p> <ul> <li>Bachelor's degree in Engineering, Life Sciences, or a related technical field</li> <li>Minimum of 5 years’ of quality systems experience with a medical device manufacturing company</li> <li>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&nbsp;</li> <li>Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality&nbsp;</li> <li>Strong technical writing skills with the ability to produce clear, compliant documentation</li> <li>Experience with statistical techniques, sampling plans, and data analysis for validation and process capability&nbsp;</li> </ul><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>