Senior Quality Systems Engineer

Senior Quality Systems EngineerBillerica, MAAccess 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.We know this list is extensive. It reflects the range of work on our team's plate, not a checklist every candidate needs to fully satisfy. If you have strong experience in some of these areas and are excited to grow into the rest, we want to hear from you.Quality Management SystemHelp maintain and continuously improve our QMSR and ISO 13485-compliant QMSSupport improvements to SOPs, work instructions, forms, test protocols, and other controlled documentsSupport document control and records management under 21 CFR Part 820Participate in internal audits and support external audits (FDA, supplier)Lead or support CAPA investigations — root cause analysis, timely closure, effectiveness verificationHelp develop quality metrics and data analysis to guide risk-based decisionsOperations & Supplier QualityPartner with Operations to help ensure manufacturing processes are controlled and validatedContribute to risk management, sterilization validation, and data integrity practicesSupport incoming inspection, nonconforming material control, and dispositionProvide Quality Engineering input on infrastructure and expansion projectsSupport supplier qualification, evaluation, and monitoringHelp conduct supplier audits and review corrective action responsesPost-Market SurveillanceSupport complaint handling, MDR reporting, and trend analysisStay current on relevant standards and regulations and help keep the team informedAssist with preparation for FDA inspections and Notified Body auditsLeadership & CultureHelp champion a proactive quality culture across a small, multidisciplinary teamOffer quality training and mentoring where you can — we all wear a few hats here!QualificationsBachelor's degree in Engineering, Life Sciences, or a related technical fieldMinimum of 5 years' of quality systems experience with a medical device manufacturing companyProven 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 14971Demonstrated experience owning a QMS end-to-end, including CAPA, document control, complaints, internal auditing, and supplier qualityStrong technical writing skills with the ability to produce clear, compliant documentationExperience with statistical techniques, sampling plans, and data analysis for validation and process capabilityCompensation Commensurate With Experience$93,000 - $160,000 USDAccess 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.