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The Quality Systems Engineer Intern will support the Quality Engineering team in maintaining and improving the Quality Management System (QMS). The intern will assist with process improvements, documentation, audits, data analysis, and compliance activities while gaining hands-on experience in quality engineering principles and industry standards

ESSENTIAL DUTIES

Assist internal and external audits to ensure compliance with company Quality Management System (QMS), GMP, ISO, and applicable regulatory requirements. Support Senior Quality team with projects involving complaint investigations, nonconforming events (NCEs), CAPA activities, and continuous quality improvement programs. Maintain quality records and documentation in compliance with

GMP, ISO

13485, FDA, and company requirements Serve as the contact for customer complaint investigations, including communication with customers regarding investigation status, findings, corrective actions, and closure Collaborate with Manufacturing, Engineering, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues and improve product quality Assist investigations involving manufacturing defects, sterilization impacts, product failures, and customer-reported issues Develop and present quality metrics, reports, and trend analyses to management. Demonstrate comfort working in manufacturing and laboratory environments, including exposure to blood-contaminated products, biological materials, odors, and medical device components during investigations and testing activities.

QUALIFICATIONS EDUCATION

Bachelor's or Master's Degree in Progress Mechanical, Industrial, Manufacturing, Biomedical or related Engineering

EXPERIENCE

Required/Preferred Academic

• Related Projects >1year Preferred Laboratory
• Quality Control or Related 1-2 years Preferred Previous Internships in Related Industries 1 year Preferred SKILLS Proficiency Software Skills Microsoft Word, Excel, PowerPoint Intermediate Data/Statistical Analysis Soft Skills Time Management, Critical Thinking, Ability to Work in a Team, Communication Bilingual
• English/Spanish
• Advanced Root Cause Analysis Compliance Attention to Detail, Ability to adhere to strict policies

Work Location:

In person