Senior Quality Systems Engineer

Access Vascular • Billerica, MA

3d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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
• 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
• 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
• Champion a proactive quality culture across a small, multidisciplinary team
• Provide quality training and mentoring to engineering, operations, and management staff

Benefits

• Commensurate With Experience $93,000 - $160,000 USD

What This Job Offers

• Job Type: Full-time
• Career Level: Senior