Senior Quality Systems Engineer

Accessvascular; Billerica (MA); On-site; USD 93,000 - 160,000; Full time

Job summary

Accessvascular in Billerica, Massachusetts, is hiring a Quality Manager to manage and improve their Quality Management System. You will play a vital role in ensuring compliance with FDA and ISO standards, leading CAPA investigations, and supporting supplier qualifications.

The ideal candidate has a Bachelor's degree in Engineering or Life Sciences and at least 5 years of experience in quality systems within the medical device industry. A competitive salary package is offered ranging from $93,000 to $160,000 USD.

Qualifications

• 5+ years of quality systems experience in medical device manufacturing.
• Proven track record of improving quality management systems compliant with FDA and ISO standards.
• Strong organizational skills and comfortable in a fast-paced environment.

Responsibilities

• Own and improve the company’s Quality Management System.
• Lead internal audits and support external audits.
• Manage complaint handling and MDR reporting processes.

Skills

Quality Management Systems

CAPA Management

Statistical Analysis

Technical Writing

Supplier Quality Management

Education

Bachelor's degree in Engineering or Life Sciences

Tools

eQMS platforms (Greenlight Guru, MasterControl)

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

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.