Final Release Specialist

Posted 6 Days Ago
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Devens, MA
In-Office
24-36 Hourly
Mid level
Software • Industrial
The Role
The Final Release Specialist ensures the completion and compliance of manufacturing records and documentation for the final release process, while collaborating with various departments to meet quality standards.
Summary Generated by Built In
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

The Quality Assurance (QA) Final Release Specialist position supports the batch final release processes. Performs functions necessary to ensure that all relevant manufacturing records and documentation are assembled, reviewed, and completed in a compliant efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable requirements.

Key Responsibilities
  • Maintain the flow of work, to include but not limited to, the setup of technical records for review, inspection,
  • Assign and track to completion all work in progress (WIP) records.
  • Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution, Engineering and all other cross functional departments to ensure commitments and customer needs are met.
  • Knowledgeable in ERP and QMS electronic systems
  • Able to identify and initiate nonconformances.
  • Responsible for the QA review of data entry, documentation, and technical and final release records.
  • Ensure that each batch is inspected per specification, physical product is verified prior to setting final disposition.
  • Review and complete records ensuring compliance with applicable SOPs, agency requirements and accreditation standards and regulatory regulations.
  • Communicates with appropriate personnel on missing required documentation, error corrections required.
  • Responsible for reporting QA variances, errors and deviations on all initiated documentation to Quality Assurance Department.
  • Organizes the flow of records through Final Release, working with Program Managers to prioritize and provide turnaround times.
  • Develops and releases controlled work instructions on the Final Release process.
  • Identifies opportunities for improvement both in the Final Release process and inputs to the Final Release process.
  • Works closely with area stakeholders that are inputs to the Final Release process to resolve issues. Develops strong working relationships and operates in a team structure.
  • Performs other duties as assigned by the Manager and Director of the Department.
Qualifications
  • 3+ years of experience in Med 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 (DHRs) and Batch Records for completeness and compliance.
  • Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.

VulcanForms offers a competitive salary and equity package. Actual compensation is based on factors such as the candidate's skills, qualifications, and experience. In addition, VulcanForms provides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with company match. 


The hourly pay range for this position is $24-$36.


Top Skills

Erp
Qms Electronic Systems
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The Company
HQ: Devens, Massachusetts
189 Employees

What We Do

VulcanForms builds and operates advanced digital manufacturing infrastructure that enables the world's critical industries to innovate, grow, and deliver sustainable impact.

A MIT-born company, VulcanForms has invented and commercialized the world’s first industrially scalable metal additive manufacturing (AM) solution and pioneered integrated digital production systems. Combining breakthrough technologies in additive and subtractive manufacturing, industrial automation, digital thread and engineering expertise, the company serves leading medical, defense, aerospace, and semiconductor companies, producing precision components and assemblies. For more information, visit www.vulcanforms.com.

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