Final Release Specialist II — Medical QA & Docs

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

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.