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