Detail-Driven Quality Control Inspector II

CooperSurgical; Trumbull (CT); On-site; USD 60,000 - 80,000; Full time

Job summary

CooperSurgical in Trumbull, CT is seeking a Quality Control Inspector II to inspect components, subassemblies, and assemblies, ensuring compliance with approved drawings, specifications, and regulatory requirements. You will document results, report defects, and support CAPA activities to maintain product quality and safety.

The role requires familiarity with cGMP and 21 CFR 820, along with experience reading engineering drawings and using inspection tools.

Qualifications

• Working knowledge of cGMP and FDA quality system regulations.
• Ability to interpret drawings, specifications, and inspection methods.
• Knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP and global standards.
• Experience reading and interpreting engineering drawings.
• Proficiency with inspection tools and measuring equipment.

Responsibilities

• Perform routine inspections of incoming materials, in-process goods, and finished products.
• Conduct visual, dimensional, mechanical, and functional inspections using approved methods.
• Ensure products comply with drawings and specifications.
• Document inspection results for traceability.
• Identify, document, and report defects or nonconformances (NCMRs).
• Provide guidance for less experienced team members.
• Assist Site Quality Management with disposition decisions per procedures.
• Collaborate cross-functionally to support investigations and issue resolution.
• Assist with CAPA activities.
• Participate in internal and external audits/inspections.
• Contribute to other quality projects as required.
• Perform other duties as assigned.

Skills

Attention to detail

Reading drawings

Communication

Problem solving

Organization

Tools

Inspection tools

Measuring equipment

Vision systems

Microsoft Excel

Microsoft Word

Outlook

PowerPoint

Job description

CooperSurgical in Trumbull, CT is seeking a Quality Control Inspector II to inspect components, subassemblies, and assemblies, ensuring compliance with approved drawings, specifications, and regulatory requirements. You will document results, report defects, and support CAPA activities to maintain product quality and safety.

The role requires familiarity with cGMP and 21 CFR 820, along with experience reading engineering drawings and using inspection tools.