Job Description
Senior Quality Systems Engineer Access Vascular Billerica, MA Job Details $93,000•$160,000 a year 1 day ago Qualifications Statistics Content creation for technical audiences Accreditation standards (regulatory compliance area) Preventive action implementation Technical writing within manufacturing Corrective and preventive actions (CAPA) Vendor compliance audits Supplier audits Manufacturing facility Production validation processes Medical device manufacturing facility experience Compliance documentation Biomedical regulatory compliance Manufacturing Customer complaint resolution
Full Job Description 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 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. .
