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 AVIs 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. .