About us

VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and pioneered integrated digital production systems. We are a team of leading technology and operational experts with decades of experience in advanced manufacturing, materials, automation, and robotics. We continuously seek contributors who demonstrate outstanding integrity, intelligence, accountability, and a passion for learning. We celebrate diversity and are committed to creating an inclusive environment for all employees.

VulcanForms Inc. seeks a Principal Quality Systems Engineer for our Devens, MA Facility

Job Purpose:

As a Principal Quality Systems Engineer, you will be responsible for ensuring the QMS is established and maintained in accordance with applicable regulatory 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 CAPA program and internal audit program 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 Accountabilities:

• 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
• Be responsible for the internal audit program
• Be responsible for 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:

• 7+ years’ experience working in the medical device field with experience in FDA regulatory requirements and ISO 13485
• Experience in writing QMS procedures
• Experience in CAPA
• Excellent communication, interpersonal and leadership skills.

Preferred:

• Experience with Start-ups
• Experience in audit support
• Experience leading and influencing across functional groups and leadership levels

Benefits:

• Medical, dental, vision, and life insurance are available to you starting on your first day of employment
• Generous time off package, including vacation PTO, sick PTO, and company-paid federal holidays
• 401(k) with company match and stock options