Final Release Specialist II - 2nd Shift

About the role

VulcanForms is a company founded in 2015 dedicated to developing laser metal additive manufacturing solutions. We operate advanced digital infrastructure to support innovation, growth, and sustainability across various industries including aerospace, defense, medical, and others. Our team combines cutting-edge technology with traditional craftsmanship to deliver scalable production.

Responsibilities

• Maintain the flow of work, including setting up technical records for review, inspection.
• 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.
• 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 each batch is inspected per specification and verify physical product before final disposition.
• Review and complete records ensuring compliance with SOPs, agency requirements, and accreditation standards and regulations.
• Communicate with appropriate personnel on missing required documentation and error corrections.
• Report QA variances, errors, and deviations to the Quality Assurance Department.
• Organize the flow of records through Final Release, prioritizing tasks and providing turnaround times.
• Develop and release controlled work instructions on the Final Release process.
• Identify opportunities for improvement in the Final Release process and inputs to the process.
• Work closely with stakeholders to resolve issues and develop strong working relationships.
• Perform 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.
• 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.

Pay

The hourly pay range for this position is $22.60-$31. This role includes a 10% pay differential for non-standard shifts. Actual compensation is based on factors such as skills, qualifications, and experience.

Benefits

• Comprehensive benefits including medical, dental, vision, and life insurance.
• Generous paid time off.
• A 401(k) plan with company match.