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 Senior Manager of Quality Control for our Devens, MA Facility

Job Purpose:

As a Senior Manager of Quality Control, you will be responsible for calibration and maintenance program management, inspection, the lab, environmental control program, and DHR management. A Candidate must have knowledge of quality systems, GD&T, inspection methods, NCR, and document control. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.

Key Accountabilities:

• Serve as a functional lead of the Quality Control department
• Accountable for calibration and maintenance program management, inspection, the lab, environmental control program, and DHR management
• Works with the Operations and Quality Engineering personnel on product quality issues and inspection activities (including development of inspection methods and technical drawing review)
• 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 tracking and trending of quality metrics/KPIs (e.g., 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
• Lead or support additional projects as assigned by QA/RA Leadership
• Support/execute other QMS elements as needed

Qualifications:

• 8+ years’ experience working in a regulated industry, with 5+ years’ experience in medical device compliant with FDA regulatory requirements and ISO 13485
• Experience in GD&T
• Experience in inspection
• Proven leadership experience with effective communication abilities
• Ability to prioritize and multitask in a dynamic environment

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