Final Release Specialist - 1st shift

VulcanForms; Harvard (MA); On-site; USD 30,307 - 42,705; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

401(k) plan with company match

Job summary

VulcanForms is seeking a Final Release Specialist II to support batch final release processes with attention to detail and compliance. The role requires 3+ years in Medical Device Manufacturing and proficiency in reviewing Device History Records. You will maintain workflow, ensure compliance with standards, and collaborate with cross-functional teams. Competitive salary range is $22-$31 per hour, with benefits including medical, dental, vision, and 401(k) matching.

Qualifications

• 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 (DHRs) and Batch Records for completeness and compliance.
• Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.

Responsibilities

• Maintain the flow of work including setup of technical records for review.
• Assign and track completion of all WIP records.
• Attend weekly planning meetings as the Quality Assurance representative.
• Ensure compliance with applicable SOPs, agency requirements, and regulatory standards.
• Communicate with personnel on missing documentation and corrections.
• Develop controlled work instructions for the Final Release process.

Skills

Medical Device Manufacturing

Reading engineering drawings

Reviewing Device History Records

Tracking nonconformances

Job description

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 Final Release Specialist II supports the batch final release processes and 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. This is a first shift role with the hours of Monday through Friday 7am - 3:30pm.

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 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 (DHRs) and Batch Records for completeness and compliance.
• Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.

VulcanFormsoffers a competitive salary and equitypackage.Actual compensation is based on factors such as the candidate's skills, qualifications, and experience.In addition,VulcanFormsprovides comprehensive benefits including medical, dental, vision, and life insurance; generous paid time off; and a 401(k) plan with companymatch.

The hourly pay range for this position is$22-$31.