Quality Control Inspector I

CooperSurgical; Trumbull (CT); On-site; USD 42,000 - 62,000; Full time

Job summary

CooperSurgical in Trumbull, CT is seeking a Quality Control Inspector I to perform routine inspections of components, subassemblies, and finished products, ensuring compliance with approved drawings and specifications.

The role supports product quality, safety, and effectiveness while maintaining cGMP and FDA Quality System Regulations. Training in measurement tools and precise documentation is essential.

Qualifications

• Must have high attention to detail and accuracy.
• Strong written and verbal communication with a variety of stakeholders.
• Proficient with 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 parts comply with drawings and specifications.
• Document inspection results to ensure traceability.
• Identify and report defects or nonconformances (NCMRs).
• Assist with disposition decisions (accept, reject, rework, return to vendor).
• Collaborate cross-functionally on investigations and quality issues.
• Support CAPA activities and audits as required.

Skills

Attention to detail

Communication skills

Excel

Word

Outlook

PowerPoint

Reading drawings/instructions

Problem solving

Inspection tools

Education

High School Diploma

Tools

Calipers

Micrometers

Gauges

Vision Systems

Job description

Scope:

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.

Job Description

Scope:

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.

Location: Trumbull, CT

Responsibilities

Job Summary:

The Quality Control Inspector I 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.

Essential Functions & Accountabilities:

• 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

n/a

Qualifications

QUALIFICATIONS

Knowledge, Skills and Abilities:

• 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)

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:

• 0+ years in medical device/healthcare manufacturing or quality inspection experience in an FDA-regulated environment.
• Certifications: ASQ Certification (Certified Quality Inspector or Certified Quality Technician) preferred but not required.

Education:

• High School Diploma or GED required.