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. Quality Management System Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS Support improvements to SOPs, work instructions, forms, test protocols, and other controlled documents Support document control and records management under 21 CFR Part 820 Participate in internal audits and support external audits (FDA, supplier) Lead or support CAPA investigations — root cause analysis, timely closure, effectiveness verification Help develop quality metrics and data analysis to guide risk-based decisions Operations & Supplier Quality Partner with Operations to help ensure manufacturing processes are controlled and validated Contribute to risk management, sterilization validation, and data integrity practices Support incoming inspection, nonconforming material control, and disposition Provide Quality Engineering input on infrastructure and expansion projects Support supplier qualification, evaluation, and monitoring Help conduct supplier audits and review corrective action responses Post-Market Surveillance Support complaint handling, MDR reporting, and trend analysis Stay current on relevant standards and regulations and help keep the team informed Assist with preparation for FDA inspections and Notified Body audits Leadership & Culture Help champion a proactive quality culture across a small, multidisciplinary team Offer quality training and mentoring where you can — we all wear a few hats here! Qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical field Minimum of 5 years' of quality systems experience with a medical device manufacturing company 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

Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier quality Strong technical writing skills with the ability to produce clear, compliant documentation Experience with statistical techniques, sampling plans, and data analysis for validation and process capability Compensation Commensurate With Experience $93,000 — $160,000 USD About Access Vascular Access Vascular 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. .