Quality Release Inspector – Shift B

About the role

CooperSurgical is seeking a Quality Release Inspector (Shift B) to ensure that finished medical device products meet all documentation and regulatory requirements before release. The role supports the Quality Control department and contributes to continuous improvement in a regulated manufacturing environment.

Key responsibilities

• Verify that production records, quality controls, and test results are complete, accurate, and compliant before releasing finished goods.
• Support QC operations in accordance with FDA 21 CFR, ISO 13485, GMPs, and other applicable regulations.
• Assist with internal and external audits related to product release and participate in root‑cause investigations.
• Notify the supervisor or quality engineer of out‑of‑spec inspection results and report significant quality incidents.
• Participate in projects, ideas, and continuous‑improvement initiatives within the work area.
• Maintain certification and training requirements for the DHR Release area.
• Perform additional tasks as assigned by management.

Required profile

• Minimum 3 years of experience in Quality Assurance or Quality Control within a regulated environment.
• Technical degree in Quality, Engineering or a related field.
• Strong attention to detail and ability to work for extended periods at a computer.

Required skills

• Proficiency with Microsoft Office applications.
• Experience using Microsoft Dynamics 365.
• Ability to read and interpret blueprints, specifications, and method sheets.