QUALITY SYSTEMS ENGINEER

QUALITY SYSTEMS ENGINEER: $75,413.00-$103,692.00/YEAR, VulcanForms (Devens, MA) VulcanForms was founded in 2015 to develop the world?s first industrially scalable laser metal additive manufacturing solution. The company builds and operates advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through vertically integrated capabilities, including scalable additive manufacturing and precision machining, VulcanForms delivers true end-to-end production at scale by combining cutting-edge technology with proven industrial craftsmanship. Its team brings expertise in manufacturing, materials science, software, automation, and operations, united by a commitment to quality, curiosity, and accountability. About the Role: VulcanForms is seeking a Quality Systems Engineer to join its Quality team in Devens, MA. The Quality Systems Engineer will help establish, maintain, and improve the Quality Management System (QMS) in accordance with applicable regulatory and industry requirements. This role will support QMS compliance by ensuring quality activities are performed according to approved procedures, policies, and regulations. Key areas of responsibility include document control, Corrective and Preventive Action (CAPA), Nonconformance Reporting (NCR), internal audits, management review, quality metrics, and QMS training. The Quality Systems Engineer will collaborate with cross-functional teams to identify compliance risks, improve processes, and implement practical, data-driven solutions. Key Responsibilities: - Help ensure the Quality Management System is established and maintained in accordance with applicable regulatory and industry requirements - Write, review, revise, and approve the release of QMS documentation and procedural changes - Support the Nonconformance Reporting program - Support the internal audit program, including preparation, execution, and follow-up activities - Support the CAPA program and track corrective and preventive actions through resolution - Support preparation and execution of Management Review activities - Support the QMS training program and help ensure personnel complete required training - Collaborate with other functions to ensure accurate, complete, and efficient change processing and document control - Track and trend quality metrics and key performance indicators, including CAPAs, nonconformances, supplier corrective actions, complaints, deviations, internal audit findings, and calibration activities - Identify improvement opportunities through data-driven analysis and present recommendations to management - Lead and support Quality System projects from planning through completion - Develop innovative and practical solutions to complex process and system problems using industry best practices - Identify and escalate compliance issues, assess their potential impact, and recommend appropriate corrective actions - Support customer, regulatory, and certification audits and inspections as needed - Coordinate audit and inspection preparation activities, including front-room and back-room support - Track audit findings and resolution activities to ensure timely closure - Lead or support additional projects assigned by Quality Systems leadership - Perform other duties as assigned by management Qualifications: - 3+ years of experience working in the medical device or aerospace industries - Experience with FDA regulatory requirements and ISO 13485, AS9100, and/or ISO 9001 standards - Experience writing, reviewing, and maintaining QMS procedures - Experience supporting NCR and CAPA processes - Experience evaluating quality metrics and KPIs - Strong written and verbal communication skills - Excellent interpersonal, organizational, and leadership skills - Ability to work effectively with cross-functional teams and mul