Final Release Specialist - 2nd Shift

VulcanForms Inc.; Ayer (MA); On-site; USD 31,684 - 42,705; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) plan

Paid time off

Equity package

Job summary

VulcanForms Inc. is seeking a Final Release Specialist II for the second shift to ensure manufacturing records and documentation are compliant and complete.

You will review DHRs and batch records, inspect batches, and coordinate with cross‑functional teams to meet regulatory standards. The role requires 3+ years in medical device manufacturing with Final Release or Document Control, and proficiency in interpreting engineering drawings.

Qualifications

• 3+ years of experience in medical device manufacturing with direct responsibility for Final Release or Document Control.
• Ability to read and interpret engineering drawings, blueprints, and technical specifications.
• 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 and inspection.
• Assign and track work in progress records to completion.
• Attend weekly planning meetings as the QA representative and collaborate with cross‑functional teams to meet commitments and customer needs.
• Knowledgeable in ERP and QMS electronic systems.
• Identify and initiate nonconformances.
• Review data entry, documentation, and final release records for QA compliance.
• Ensure each batch is inspected per specification and verified prior to final disposition.
• Review and complete records ensuring compliance with SOPs, agency requirements and regulatory standards.
• Communicate missing documentation or required corrections to appropriate personnel.
• Report QA variances, errors and deviations on all initiated documentation to QA Department.
• Organize the flow of records through Final Release, prioritizing turnaround times with Program Managers.
• Develop and release controlled work instructions for Final Release.
• Identify opportunities for improvement in the Final Release process.
• Work with area stakeholders to resolve issues and build strong working relationships.
• Perform other duties as assigned by the Manager and Director.

Skills

Reading engineering drawings

DHRs and Batch Records review

CAPAs and nonconformances

ERP & QMS knowledge

Tools

ERP systems

QMS software

Job description

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 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 and 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 second shift role with the hours of Monday through Friday, 3 pm – 11 pm.

Key Responsibilities

• Maintain the flow of work, including setup of technical records for review and inspection.
• Assign and track work in progress records to completion.
• Attend weekly planning meetings as the Quality Assurance representative and collaborate with Operations, Customer Service, Distribution, Engineering and other cross‑functional departments to ensure commitments and customer needs are met.
• Knowledgeable in ERP and QMS electronic systems.
• Identify and initiate nonconformances.
• Review data entry, documentation, and technical and final release records for QA compliance.
• Ensure that each batch is inspected per specification and that the physical product is verified prior to final disposition.
• Review and complete records ensuring compliance with applicable SOPs, agency requirements, accreditation standards and regulatory regulations.
• Communicate with appropriate personnel about missing documentation or required error corrections.
• Report QA variances, errors and deviations on all initiated documentation to the Quality Assurance Department.
• Organize the flow of records through Final Release, prioritizing turnaround times with Program Managers.
• Develop and release controlled work instructions for the Final Release process.
• Identify opportunities for improvement in the Final Release process.
• Work closely with area stakeholders who are part of the Final Release process to resolve issues and build strong working relationships within the team structure.
• Perform 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.
• Experience reviewing Device History Records (DHRs) and Batch Records for completeness and compliance.
• Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure.

Compensation and Benefits

The hourly pay range for this position is $22.60–$31.00, with a 10% shift differential for non‑standard shifts. VulcanForms offers a competitive salary and equity package. 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.