Quality Systems Engineer
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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.
Job Purpose
As 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 Responsibilities
Ensure that a Quality System is established and maintained to the highest levels of accordance with applicable regulatory requirements
Write, review, and approve the release of changes to QMS documentation
Support the NCR program
Support the internal audit program
Support the CAPA program
Support the preparation of Management Review
Support the QMS training program
Work with other functions to ensure accurate, complete, and efficient change processing and document control activities
Support 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 management
Lead/support Quality System projects effectively
Develop innovative and practical solutions to complex and unique process problems and systematic improvements through the use of best practices
Identify/escalate any compliance issues and their potential impact and provide potential solutions/actions so that they can be effectively resolved
Support audits and inspections as needed (e.g., coordinate preparation activities, FR/BR support, track resolution activities
Lead or support additional projects as assigned by QS Leadership
Qualifications
3+ years’ experience working in the medical device or aerospace fields with experience in FDA regulatory requirements, ISO 13485, and/or AS9100/ISO9001
Experience in writing QMS procedures
Experience in NCR and CAPA
Excellent communication, interpersonal and leadership skills
Experience working with and evaluating Quality metrics and KPIs
Preferred Qualifications
Experience with Start-ups
Experience in audit support
Experience leading and influencing across functional groups and leadership levels
VulcanFormsoffers 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.
The annual base salary range for this position is $75,413.00 to $103,692.00.
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