Sr. Quality Systems Engineer

Location: Devens

About UsFounded in 2015 to develop the world’s first industrially scalable laser metal additive manufacturing solution, Vulcan Forms 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 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

Qualifications5+ years experience working in a regulated field with experience in quality systems

Experience in writing QMS procedures

Experience in NCR and CAPAExcellent communication, interpersonal and leadership skills

Experience working with and evaluating Quality metrics and KPIsPreferred 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

Vulcan Forms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, Vulcan Forms 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.