Senior Quality Systems Engineer

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.

• 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

• 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

• 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

• 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
• 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. .