Quality Assurance Inspection Lead

As a Quality Assurance Inspection Lead, you will serve as a critical link in our operations by overseeing the validation and release of incoming materials. You will drive operational excellence by ensuring all components meet rigorous regulatory standards, directly impacting patient safety and product reliability in a fast-paced manufacturing environment.

• Direct daily receiving inspection workflows to ensure all incoming components and subassemblies meet strict quality specifications.
• Utilize precision measurement tools to verify materials against engineering drawings and technical requirements.
• Manage the Material Review Board (MRB) process to resolve nonconformances and maintain inventory integrity.
• Facilitate the timely release of compliant materials to production to keep operations running smoothly.
• Maintain audit-ready documentation and support regulatory inspections, including those from the FDA.
• Mentor and train inspection staff on best practices, inspection methodologies, and quality compliance.
• Identify and implement process improvements to enhance inspection efficiency and overall quality outcomes.
• Ensure all inspection equipment remains calibrated and fully functional for accurate testing.

Qualifications

Required Skills

• 3–7 years of experience in quality inspection within a highly regulated industry.
• Deep understanding of FDA 21 CFR Part 820 and ISO 13485 standards.
• Proven ability to interpret complex engineering drawings and technical specifications.
• Proficiency with measurement instrumentation such as calipers, micrometers, and vision systems.
• High school diploma or equivalent.

Preferred Skills

• Associate or Bachelor’s degree in Engineering, Quality, or a related technical field.
• Prior experience in a leadership or supervisory capacity.
• Working knowledge of ERP systems and electronic quality management software.
• Experience with statistical sampling plans and advanced inspection techniques.