{"schemaVersion":"jobsearcher.job.v1","id":"495815d0f2ce3483915ba4e6","url":"https://jobsearcher.com/jobs/495815d0f2ce3483915ba4e6","canonicalUrl":"https://jobsearcher.com/jobs/495815d0f2ce3483915ba4e6","title":"Quality Systems Engineer","description":"Founded 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.\n\nJob Purpose\n\nAs 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.\n\nKey Responsibilities\n\nEnsure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirements\n\nWrite, review, and approve the release of changes to QMS documentation\n\nSupport the NCR program\n\nSupport the internal audit program\n\nSupport the CAPA program\n\nSupport the preparation of Management Review\n\nSupport the QMS training program\n\nWork with other functions to ensure accurate, complete, and efficient change processing and document control activities\n\nSupport the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration, etc.\n\nIdentify areas of improvement through data-driven trending and bring solutions to management\n\nLead/support Quality System projects effectively\n\nDevelop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practices\n\nIdentify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved\n\nSupport audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities\n\nLead or support additional projects as assigned by QS Leadership\n\nQualifications\n\n3+ years’ experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001\n\nExperience in writing QMS procedures\n\nExperience in NCR and CAPA\n\nExcellent communication, interpersonal and leadership skills\n\nExperience working with and evaluating Quality metrics and KPIs\n\nPreferred Qualifications\n\nExperience with Start-ups\n\nExperience in audit support\n\nExperience leading and influencing across functional groups and leadership levels\n\nVulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate's skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.\n\nThe annual base salary range for this position is $75,413.00 to $103,692.00.\n\n#J-18808-Ljbffr","company":"Vulcanforms","rawCompany":"vulcanforms","city":"Harvard","state":"MA","isRemote":false,"isActive":true,"createdAt":"2026-06-27T03:21:24.511Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Systems Engineer","description":"Founded 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.\n\nJob Purpose\n\nAs 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.\n\nKey Responsibilities\n\nEnsure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirements\n\nWrite, review, and approve the release of changes to QMS documentation\n\nSupport the NCR program\n\nSupport the internal audit program\n\nSupport the CAPA program\n\nSupport the preparation of Management Review\n\nSupport the QMS training program\n\nWork with other functions to ensure accurate, complete, and efficient change processing and document control activities\n\nSupport the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration, etc.\n\nIdentify areas of improvement through data-driven trending and bring solutions to management\n\nLead/support Quality System projects effectively\n\nDevelop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practices\n\nIdentify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved\n\nSupport audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities\n\nLead or support additional projects as assigned by QS Leadership\n\nQualifications\n\n3+ years’ experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001\n\nExperience in writing QMS procedures\n\nExperience in NCR and CAPA\n\nExcellent communication, interpersonal and leadership skills\n\nExperience working with and evaluating Quality metrics and KPIs\n\nPreferred Qualifications\n\nExperience with Start-ups\n\nExperience in audit support\n\nExperience leading and influencing across functional groups and leadership levels\n\nVulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate's skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.\n\nThe annual base salary range for this position is $75,413.00 to $103,692.00.\n\n#J-18808-Ljbffr","datePosted":"2026-06-27T03:21:24.511Z","dateModified":"2026-06-27T03:21:24.511Z","hiringOrganization":{"@type":"Organization","name":"Vulcanforms","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"495815d0f2ce3483915ba4e6"},"url":"https://jobsearcher.com/jobs/495815d0f2ce3483915ba4e6"}}