Final Release QA Specialist – Medical Devices (Equity)

VulcanForms; Harvard (MA); On-site; USD 30,307 - 42,705; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Generous paid time off

401(k) plan with company match

Job summary

VulcanForms is seeking a Final Release Specialist II to support batch final release processes with attention to detail and compliance. The role requires 3+ years in Medical Device Manufacturing and proficiency in reviewing Device History Records. You will maintain workflow, ensure compliance with standards, and collaborate with cross-functional teams. Competitive salary range is $22-$31 per hour, with benefits including medical, dental, vision, and 401(k) matching.

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.
• 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.

Responsibilities

• Maintain the flow of work including setup of technical records for review.
• Assign and track completion of all WIP records.
• Attend weekly planning meetings as the Quality Assurance representative.
• Ensure compliance with applicable SOPs, agency requirements, and regulatory standards.
• Communicate with personnel on missing documentation and corrections.
• Develop controlled work instructions for the Final Release process.

Skills

Medical Device Manufacturing

Reading engineering drawings

Reviewing Device History Records

Tracking nonconformances

Job description

VulcanForms is seeking a Final Release Specialist II to support batch final release processes with attention to detail and compliance. The role requires 3+ years in Medical Device Manufacturing and proficiency in reviewing Device History Records. You will maintain workflow, ensure compliance with standards, and collaborate with cross-functional teams. Competitive salary range is $22-$31 per hour, with benefits including medical, dental, vision, and 401(k) matching.