Final Release Specialist II: Medical Device QA & Documentation

VulcanForms Inc.; Harvard (MA); On-site; USD 30,000 - 43,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid time off

401(k) with company match

Job summary

VulcanForms Inc. is seeking a Final Release Specialist II to support batch final release processes and ensure manufacturing records are complete and compliant.

This first shift role runs Monday through Friday, 7am to 3:30pm, with responsibility for QA review and cross-functional coordination to meet customer needs. The ideal candidate has 3+ years in medical device manufacturing focused on final release or document control, with strong skills in reading engineering drawings, DHRs, and CAPA

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.

Responsibilities

• Maintain flow of work and set up technical records for review and inspection.
• Assign and track completion of all in-progress records.
• Attend weekly planning meetings as QA representative and coordinate with cross-functional teams.
• Be knowledgeable in ERP and QMS electronic systems.
• Identify and initiate nonconformances.
• QA review data entry, documentation, and final release records.
• Ensure each batch is inspected per specification and verified before final disposition.
• Review and complete records for SOPs, agency requirements, and regulatory standards.
• Communicate missing documentation and required corrections.
• Report QA variances, errors, and deviations to QA Department.
• Organize flow of records through Final Release with program managers.
• Develop and release controlled work instructions for Final Release.
• Identify improvement opportunities in Final Release processes.
• Collaborate with area stakeholders to resolve issues and maintain teamwork.
• Perform other duties as assigned by Manager and Director.

Skills

Medical Device Manufacturing

Final Release

Document Control

Tools

ERP

QMS

Job description

VulcanForms Inc. is seeking a Final Release Specialist II to support batch final release processes and ensure manufacturing records are complete and compliant.

This first shift role runs Monday through Friday, 7am to 3:30pm, with responsibility for QA review and cross-functional coordination to meet customer needs. The ideal candidate has 3+ years in medical device manufacturing focused on final release or document control, with strong skills in reading engineering drawings, DHRs, and CAPA