Quality Release Inspector II

About the role

The Quality Release Inspector II ensures that final product documentation meets all regulatory, technical, and safety standards before release. Working closely with production, engineering, and quality teams, this role safeguards product compliance and supports continuous improvement.

Key responsibilities

• Verify completeness and accuracy of production and quality records for batch release.
• Support Quality Control operations in compliance with FDA 21 CFR, ISO 13485, GMPs, and related regulations.
• Assist internal and external audits, root‑cause investigations, and non‑conformance events.
• Execute batch releases in the QMS/ERP system and generate Certificates of Analysis.
• Maintain Device History Records (DHR) storage and ensure no open quality figures block release.
• Participate in projects, procedural updates, and continuous‑improvement initiatives.
• Notify supervisors of out‑of‑spec inspection results or significant documentation issues.

Required profile

• 2+ years of experience in Quality Assurance or Quality Control.
• Technical degree in Quality or a related field.
• Strong attention to detail and ability to work under pressure.
• Familiarity with production, clean‑room, or warehouse environments.

Required skills

• Proficiency with Microsoft Office.
• Experience using Dynamics 365.
• Knowledge of QMS/ERP systems for batch release.
• Working knowledge of FDA 21 CFR, ISO 13485, and GMP regulations.