Quality Control Engineer
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 Quality Control Engineer for our Devens, MA Facility
As a Quality Control Engineer, you will be responsible for the calibration and maintenance program management, the environmental control program, and DHR management. A candidate must have knowledge of quality systems, and a preferred candidate would have experience in GD&T, inspection methods, NCR, and writing procedures. QMS compliance will be met by ensuring that activities previously noted are conducted according to prescribed procedures, policies, and regulations.
- Responsible for calibration and maintenance program management, environmental control program, and DHR management
- 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.
- 3+ years’ experience working in a regulated industry, ideally in medical device compliant with FDA regulatory requirements and ISO 13485
- Excellent communication, interpersonal and leadership skills.
- Ability to prioritize and multitask in a dynamic environment
- Experience with Start-ups
- Experience in GD&T
- Experience in inspection
- Experience in NCR
- Experience in writing procedures
- Experience leading and influencing across functional groups and leadership levels
- 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