Quality Control Inspector II

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Trumbull, CT (on-site)

Scope: 

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

Job Summary:

The Quality Control Inspector 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.

• 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.

Travel: This position may require 5-10% domestic travel.

Knowledge, Skills and Abilities:

• 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.
• 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.

Work Environment:

• Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day. 

• Occasional lifting up to 35 pounds.

Experience:

• 2+ years in medical device/healthcare manufacturing or quality inspection experience