Sr. Quality Systems Engineer

VulcanForms Inc.; Harvard (MA); On-site; USD 75,000 - 104,000; Full time

Benefits offered by this job

Equity

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan with company match

Paid time off

Job summary

VulcanForms Inc. is seeking a Quality Systems Engineer to establish and maintain the QMS in line with FDA and ISO requirements. You will write procedures, manage CAPA and NCR processes, and partner with cross-functional teams to ensure compliant quality practices.

The role includes internal audits, management review, QMS training, KPI tracking, and leading quality system projects while identifying improvements and escalating issues as needed.

Qualifications

• 3+ years' experience in medical device or aerospace with FDA/regulatory exposure.
• Experience writing QMS procedures.
• Experience with NCR and CAPA processes.
• Excellent communication, interpersonal and leadership skills.
• Experience evaluating quality metrics and KPIs.

Responsibilities

• Establish and maintain a Quality System per regulatory requirements.
• Write, review, and approve changes to QMS documentation.
• Support the NCR program
• Support the internal audit program
• Support the CAPA program
• Prepare Management Review
• Support the QMS training program
• Coordinate change processing and document control with other functions
• Track and trend quality metrics/KPIs
• Identify improvement opportunities through data-driven analysis
• Lead or support Quality System projects
• Develop practical solutions for process problems
• Escalate compliance issues and propose actions
• Support audits and inspections
• Lead or support additional QS projects

Skills

FDA regulatory

ISO 13485

AS9100/ISO9001

QMS procedures

NCR

CAPA

KPIs

leadership

communication

Job description

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.

Job Purpose

As aQuality 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.