Quality Control Inspector II

CooperSurgical; Trumbull (CT); On-site; USD 55,000 - 75,000; Full time

Job summary

CooperSurgical is seeking a Quality Control Inspector II to perform routine inspections of components, in-process goods, and finished products to ensure compliance with drawings and regulatory requirements. The role supports product quality, safety, and effectiveness under cGMP, FDA QSR, and global standards.

Responsibilities include visual and dimensional inspections, determining disposition with QA, and guiding less experienced team members.

Qualifications

• Knowledge of cGMP, FDA QSR, and quality inspection practices in regulated environments.
• Ability to interpret drawings, specifications, and inspection methods.
• Experience with 21 CFR 820, ISO 13485, EU MDR, MDSAP and other global standards.
• Experience reading and interpreting engineering drawings.
• Proficiency with inspection tools and measuring equipment.
• Experience with vision systems and automated inspection systems.
• Strong attention to detail and accuracy.
• Strong communication skills with stakeholders.
• Proficient in Microsoft Excel, Word, Outlook, and PowerPoint.

Responsibilities

• Perform routine and detailed inspections of incoming materials, in-process goods, and finished products.
• Conduct visual, dimensional, mechanical, and functional inspections using approved methods and equipment.
• Ensure components, subassemblies, and finished products comply with drawings and specifications.
• Document inspection results to ensure full traceability.
• Identify, document, and report defects or nonconformances.
• Provide guidance for less experienced team members.
• Support Site Quality Management in disposition decisions per procedures.
• Collaborate cross-functionally to assist investigations and resolve quality issues.
• Support CAPA activities and participate in audits and inspections.

Skills

Visual inspection

Reading drawings

Documentation

Clear communication

Tools

Measuring equipment

Vision systems

Job description

Job Description

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.