The Customer Reports and Complaint Handling Intern will assist in the processing, investigation, and trending of product defect complaints, supporting the documentation and resolution of customer reports and complaints in accordance with New World Medical’s policies and regulatory requirements. This internship provides valuable hands-on experience in complaint handling, adverse event reporting, returned product disposition, and data analysis for monitoring and process improvement. 

The intern will work closely with the Customer Reports and Complaint Handling team to track investigation progress, contribute to complaint processing system optimization, and support corrective and preventive actions related to product complaints. This position may also involve interactions with surgical sales consultants, customer service, production, clinical research, and medical advisory teams for education and training purposes. 

LEARNING OPPORTUNITIES AND EXPERIENCE: 

During this internship, the intern will gain real-world experience in Quality Assurance and Regulatory Affairs within the medical device industry. This hands-on experience will include: 

• Regulatory Compliance and Quality Systems Exposure: Learn how FDA (21 CFR 820), ISO 13485, and MDR (Medical Device Regulation - EU) and other applicable regulatorions apply to complaint handling and post-market surveillance. Understand how to process customer complaints in a compliant manner and how companies maintain documentation for regulatory audits and inspections. Participate in internal audits to gain exposure to regulatory inspection readiness and quality system compliance. 
• Complaint Handling and Investigation Process: Learn how to properly intake, document, and categorize customer complaints in accordance with quality system procedures. Assist in root cause analysis and help determine potential corrective and preventive actions (CAPA). Work with engineering and quality teams to analyze product failure trends and support investigation processes. Participate in returned product evaluations and learn how quality professionals assess defects. 
• Data Analysis and Reporting: Assist in data collection and trend analysis to identify common complaint issues and areas for product improvement. Learn how to prepare executive summaries and complaint trend reports for management. Gain experience using data analysis tools such as Excel, Minitab, and statistical process control (SPC) techniques. 
• Cross-Functional Collaboration and Industry Insights: Work closely with surgical sales consultants, customer service, and production teams to gather information and ensure complaint resolution. Gain exposure to real-world problem-solving in the medical device industry, learning how different departments collaborate to address product quality concerns. 
• Professional Development and Career Growth: Enhance critical thinking, attention to detail, and regulatory knowledge, all essential skills for careers in Quality Assurance, Regulatory Affairs, and Product Development. Receive mentorship from experienced quality and regulatory professionals, providing insights into career paths in the medical device industry. Develop professional communication skills by working with cross-functional teams and preparing formal reports. 

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:  

• Ensure all work is performed in compliance with company policy and within the guidelines of New World Medical’s Quality System.  
• Supervise the investigation, resolution, and reporting of all customer-related complaints.  
• Oversee visual inspection of returned products, review Device History Records for compliance, maintain RGA/CFB Logs, complete sample investigation, and closure of customer evaluation reports in accordance with existing regulations and guidelines.  
• Coordinate with other departments to obtain necessary information/updates for the resolution of complaints.  
• Lead in preparing, compiling, and coordinating reports/data analysis for presentation to upper Management in the form of executive summaries.  
• Oversee data input into quality database (SPC) to maintain SPC charts and analyze results.  
• Prepare standardized work instructions and procedures and facilitate effective communication of procedures to affected areas.  
• Undertake and complete assignments as determined by Quality Manager or from the department head. 
• Participate in facility audits (Notified Body, Internal Audit, etc.) 

KNOWLEDGE, SKILLS AND ABILITIES:  

• Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas. 
• Ability to communicate in writing and orally with supervisors and co-workers.  
• Good understanding of operational environment and analytical skills.  
• Must be self-motivated and a good team player.  
• Proficiency in using Microsoft Office Applications (MS Word, MS Excel, MS PP, MS Outlook).  
• Familiarity with Quality System and complaint handling is a plus.  
• Experience with SAP, MiniTab, and SOP writing is a plus. 

EDUCATION AND EXPERIENCE: 

• Currently pursuing or recently completed a Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Quality Management, or a related field. 
• Previous internship or coursework related to Quality, Regulatory, or Medical Devices is a plus. 
• Training or familiarity with complaint handling procedures is a plus. 

PHYSICAL REQUIREMENTS:  

• Able to lift up to 25 pounds. This may be performed with reasonable accommodation.  
• Must be able to remain in a stationary position at least 50% of the time.  
• Occasionally move about inside the office and travel to and from office buildings; this may include bending and walking.  
• Must be able to operate a computer and other office productivity machinery.  
• Ability to listen and speak with employees, suppliers, auditors, customers, and distributors. Must be able to exchange accurate information in these situations.  
• View and type on computer screens for long periods of time 

This description reflects management’s assignment of essential functions; it does not proscribe or restrict the tasks that may be assigned.