Quality Systems Engineer

Quality Systems EngineerFounded in 2015 to develop the world's first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products. We build and operate advanced digital infrastructure that enables innovation, accelerates growth, and supports sustainability across aerospace, defense, medical, and other essential industries. Through our vertically integrated capabilities, including scalable additive manufacturing and precision machining, we deliver true end-to-end production at scale by combining cutting-edge technology with a foundation of proven industrial craftsmanship. Our team brings deep expertise in manufacturing, materials science, software, automation, and operations, united by a shared commitment to quality, curiosity, and accountability. We foster an inclusive culture where people take ownership, solve meaningful problems, and continuously learn, because we believe diverse perspectives lead to better outcomes.Job PurposeAs a Quality Systems Engineer, you will be responsible for helping to ensure the QMS is established and maintained in accordance with applicable regulatory requirements. A candidate must have knowledge of quality systems, CAPA, NCR, and document control. This position is responsible for writing and updating QMS procedures and is accountable for ensuring quality processes are executed compliantly. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.Key ResponsibilitiesEnsure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirementsWrite, review, and approve the release of changes to QMS documentationSupport the NCR programSupport the internal audit programSupport the CAPA programSupport the preparation of Management ReviewSupport the QMS training programWork with other functions to ensure accurate, complete, and efficient change processing and document control activitiesSupport the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration, etc.Identify areas of improvement through data-driven trending and bring solutions to managementLead/support Quality System projects effectivelyDevelop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practicesIdentify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolvedSupport audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activitiesLead or support additional projects as assigned by QS LeadershipQualifications3+ years' experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001Experience in writing QMS proceduresExperience in NCR and CAPAExcellent communication, interpersonal and leadership skillsExperience working with and evaluating Quality metrics and KPIsPreferred QualificationsExperience with Start-upsExperience in audit supportExperience leading and influencing across functional groups and leadership levelsVulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match.The annual base salary range for this position is $75,413.00 to $103,692.00.