Senior Quality Systems Engineer

Senior Quality Systems EngineerManage 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. This is a key contributor position working closely among the AVI team with AVI's QMS and FDA QMSR requirements.Responsibilities:Quality Management SystemOwn, maintain, and continuously improve the company's QMSR and ISO 13485-compliant QMSDrive continuous improvement to company SOPs, work instructions, forms, test protocols, infrastructure software and other controlled documentsManage document control and records management in compliance with 21 CFR Part 820Lead internal audits and support external audits (FDA, Supplier)Lead CAPA investigations to root cause, ensuring timely closure and effectiveness verificationDevelop and communicate quality metrics and data analysis to inform continuous improvement and risk-based decision makingLead statistical methods development for quality metrics, inspection planning, and continuous improvement initiativesOperations & Supplier QualityCollaborate with Operations to ensure manufacturing processes are controlled and validatedAct a subject matter expert (SME) for risk management, sterilization validation, and data integrity and how it defines validation, verification, and inspection sampling rigorSupport incoming inspection, nonconforming material control, and disposition activitiesProvide Quality Engineering support to infrastructure move and expansion projectsManage supplier qualification, evaluation, and monitoring programsConduct supplier audits and review supplier corrective action responsesPost-Market SurveillanceManage complaint handling, MDR reporting processes, and trend analysisMaintain knowledge of applicable standards and regulations and communicate updates to the teamAssist in preparation for and response to FDA inspections and Notified Body auditsLeadership & CultureChampion a proactive quality culture across a small, multidisciplinary teamProvide quality training and mentoring to engineering, operations, and management staffQualifications: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. Highly organized, self-directed, and comfortable in a fast-paced environment. ASQ Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), or equivalent is a plus. Lead auditor certification (ISO 13485 or equivalent) is a plus. Experience with implementing and validating eQMS platforms (e.g., Greenlight Guru, MasterControl, ETQ) is a plus. Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus. Experience supporting 510(k) submissions or technical files for CE marking is a plus. Prior experience at a startup or early-stage medical device company is a plusCompensation Commensurate With Experience$93,000 - $160,000 USDAbout Access VascularAccess 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.