About the role
Job Purpose
As a Senior Quality Systems Engineer, you will be responsible for ensuring the QMS is established and maintained in accordance with applicable industry requirements. A candidate must have knowledge of quality systems, CAPA, internal audit, and document control. This position is responsible for writing and updating QMS procedures and is accountable for ensuring the NC, CAPA and internal audit programs are defined and 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 the 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
Prepare and deliver QMS training
Support the tracking and trending of quality metrics/KPIs (e.g., CAPAs, NCs, SCARs, complaints, deviations, internal audit findings, calibration and PM, etc.)
Identify areas of improvement through data-driven trending and brings solutions to management
Lead/support significant Quality System projects effectively
Develop innovative and practical solutions to complex and unique process problems and system improvement 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 QA/RA Leadership
Support/execute other QMS elements as needed
Qualifications
5+ years experience working in a regulated field with experience in quality systems
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
Working knowledge of ISO 13485, ISO 9001, and AS9100
VulcanForms 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 $90,104 to $123,893.
About Us
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.