Quality Systems Engineer Intern

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

Quality Systems Engineer Intern

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