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 Management System Regulations (21 CFR 820), and other applicable quality standards.
Work Environment:
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.
The Quality Control Inspector I is responsible for inspecting components, subassemblies, and assemblies within the Cooper Surgical Stafford, TX facility. The Quality Control Inspector 1 will ensure components, subassemblies, and assemblies comply with approved specifications.
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, Microsoft Teams, 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)
Essential Functions & Accountabilities:
Travel : 5-10%
