Final Release Specialist - 1st shift

About the role

VulcanForms is reshaping how the world manufactures critical products through its vertically integrated capabilities, including scalable additive manufacturing and precision machining. This role supports the batch final release processes and ensures all relevant manufacturing records and documentation are assembled, reviewed, and completed in a compliant and efficient manner.

Responsibilities

• Maintain the flow of work, to include but not limited to, the setup of technical records for review, inspection.
• Attend weekly planning meetings as the Quality Assurance representative and work with Operations, Customer Service, Distribution, Engineering, and other cross-functional departments to ensure commitments and customer needs are met.
• Knowing 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.
• Ensures each batch is inspected per specification, physical product is verified prior to setting final disposition.
• Reviews and completes 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.
• Reports 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.
• 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.

Benefits

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 $22-$31.