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

Job Description

Scope: The Quality Control Inspector II is responsible for inspecting components, subassemblies, and assemblies within the CooperSurgical Trumbull, CT facility. The Quality Control inspector II will ensure components, subassemblies, and assemblies comply with approved specifications. The Quality Control Inspector II is responsible for performing routine inspections of components, subassemblies, and finished products to ensure compliance with approved drawings, specifications, inspection plans, and regulatory requirements. This role supports product quality, safety, and effectiveness while maintaining compliance with current Good Manufacturing Practices (cGMP), FDA Quality System Regulations (21 CFR 820), and other applicable quality standards.

Responsibilities

• Perform routine and detailed inspections of incoming materials, in-process goods, and finished products.
• Conduct visual, dimensional, mechanical, and functional inspection using approved methods, tools, and equipment.
• Ensure components, subassemblies, and finished products comply with approved company drawings and specifications.
• Document inspection results to ensure full traceability.
• Identify, document, and report defects or nonconformances (NCMRs)
• Provide guidance for less experienced team members
• Support Site Quality Management in determining disposition of product (accept, reject, rework, return to vendor) in accordance with approved company procedures.
• Collaborate cross-functionally to assist with investigations and resolve potential quality issues.
• Support corrective and preventive action (CAPA) activities.
• Participate in internal and external audits and inspections as required.
• Participate in other projects as required by Quality Management.
• Perform other duties as assigned.

Qualifications

• Working knowledge of cGMP, FDA quality system regulations, and quality inspection practices in a regulated environment.
• Ability to interpret drawings, specifications, and inspection methods.
• Working knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards
• Experience and ability in reading and interpreting engineering drawings.
• Proficiency using inspection tools and measuring equipment.
• Experience using vision systems and other automated inspection systems.
• Strong attention to detail and accuracy.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Strong organizational, troubleshooting, and problem-solving skills.