Senior Quality Systems Engineer

Job Descriptions: Manage 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 System • Own, maintain, and continuously improve the company's QMSR and ISO 13485-compliant QMS • Drive continuous improvement to company SOPs, work instructions, forms, test protocols, infrastructure software and other controlled documents • Manage document control and records management in compliance with 21 CFR Part 820 • Lead internal audits and support external audits (FDA, Supplier) • Lead CAPA investigations to root cause, ensuring timely closure and effectiveness verification • Develop and communicate quality metrics and data analysis to inform continuous improvement and risk-based decision making • Lead statistical methods development for quality metrics, inspection planning, and continuous improvement initiatives Operations & Supplier Quality • Collaborate with Operations to ensure manufacturing processes are controlled and validated • Act a subject matter expert (SME) for risk management, sterilization validation, and data integrity and how it defines validation, verification, and inspection sampling rigor • Support incoming inspection, nonconforming material control, and disposition activities • Provide Quality Engineering support to infrastructure move and expansion projects • Manage supplier qualification, evaluation, and monitoring programs • Conduct supplier audits and review supplier corrective action responses Post-Market Surveillance • Manage complaint handling, MDR reporting processes, and trend analysis • Maintain knowledge of applicable standards and regulations and communicate updates to the team • Assist in preparation for and response to FDA inspections and Notified Body audits Leadership & Culture • Champion a proactive quality culture across a small, multidisciplinary team • Provide quality training and mentoring to engineering, operations, and management staff 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 • 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 plus 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. .

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