Quality Control Inspector I

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:

• 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.

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:

• 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 in ensuring 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: 5-10%

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 in ensuring 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: 5-10%