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 companys 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:

Bachelors 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

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. .