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VulcanForms

Metal 3D printing integrated production system

Final Release Specialist

Validation, Compliance & Quality SystemsUpdated on Nov 14
Full-timeDevens, MA, USA

About the Job

Requirements

  • At least 3 years of experience in medical device manufacturing with direct responsibility for final release or document control.
  • Proficiency in reading and interpreting engineering drawings, blueprints, and technical specifications.
  • Demonstrated experience reviewing Device History Records and batch records for completeness and compliance.
  • Experience initiating, documenting, and tracking nonconformances, deviations, and corrective and preventive actions to closure.

Responsibilities

  • Maintain the flow of work, including setting up technical records for review and inspection.
  • Assign and track all work-in-progress records through completion.
  • Attend weekly planning meetings as the Quality Assurance representative and coordinate with Operations, Customer Service, Distribution, Engineering, and other cross-functional departments to meet commitments and customer needs.
  • Use enterprise resource planning and quality management system electronic systems.
  • Identify and initiate nonconformances.
  • Review data entry, documentation, and technical and final release records for quality assurance.
  • Ensure each batch is inspected per specification and verify the physical product before setting final disposition.
  • Review and complete records for compliance with applicable standard operating procedures, agency requirements, accreditation standards, and regulations.
  • Communicate missing required documentation and required error corrections to appropriate personnel.
  • Report quality assurance variances, errors, and deviations on initiated documentation to the Quality Assurance Department.
  • Organize the flow of records through Final Release, working with Program Managers to prioritize work and provide turnaround times.
  • Develop and release controlled work instructions for the Final Release process.
  • Identify opportunities to improve the Final Release process and its inputs.
  • Work with area stakeholders who provide inputs to the Final Release process to resolve issues and maintain effective working relationships within a team structure.
  • Perform other duties as assigned by the Manager and Director of the Department.

About the Company

VulcanForms

Metal 3D printing integrated production system

VulcanForms provides metal additive manufacturing services through an end-to-end digital production system. It builds and runs its own US-based foundries to produce metal parts, components, and assemblies for industries like aerospace, defense, and medical devices. The core of its offering is an integrated platform that combines proprietary simulation tools, in-process sensing, and machine learning to enable high-precision, quality-controlled production at greater speed and scale than traditional metal manufacturing. In contrast to many competitors that rely on external capacity, VulcanForms owns the entire production chain from design to finished part, emphasizing domestic, high-volume fabrication. The company’s goal is to deliver high-performance metal components with reliable predictable quality and faster lead times, strengthening customers’ supply chains and enabling large-scale production of critical parts.

Company size
201-500
Company stage
Debt Financing
Total funding
$1.1B
Headquarters
Newbury, MA
Founded
2015

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