Senior Quality Systems Engineer

Job Description s:

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, Master Control, 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. .