Quality Control Inspector I

CooperCompanies•Trumbull, CT

10d•Onsite

About The Position

The Quality Control Inspector I is responsible for inspecting components, subassemblies, and assemblies within the CooperSurgical Trumbull, CT facility. The Quality Control inspector I will ensure components, subassemblies, and assemblies comply with approved specifications. 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.

Requirements

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.
Ability to read, interpret and execute work Instructions and procedures.
Basic understanding of Quality Standard.
Ability to compare products to specifications, drawings or samples.
Problem-solving mindset.
Ability to use inspection tools (Calipers, micrometers, Gauges or Vision Systems).
0+ years in medical device/healthcare manufacturing or quality inspection experience in an FDA-regulated environment.
High School Diploma or GED required.

Nice To Haves

ASQ Certification (Certified Quality Inspector or Certified Quality Technician) preferred but not required.

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).
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.