Quality Systems & Regulatory Affairs CO-OP

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position Overview: We are seeking a motivated Quality Systems & Regulatory Affairs CO-OP to join our team for a hands-on learning experience in medical device quality assurance and regulatory compliance. This position provides valuable exposure to quality management systems in a fast-paced medical technology environment.

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues
• Gain a deeper understanding of a Quality Management System and Quality Processes through the design and implementation of documentation reflective of processes including CAPA, Complaint, Nonconformances, and Audit processes
• Work to implement changes to a Quality Management System
• Own improvements to current processes and procedures, along with opportunities to create new processes
• Support Quality and Regulatory Affairs team through the implementation of quality systems software
• Collaborate with cross-functional teams including R&D, Operations, and Regulatory Affairs

Required Qualifications:

• Currently pursuing a Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related technical field
• Strong attention to detail and analytical skills
• Basic understanding of quality management principles
• Excellent written and verbal communication abilities
• Ability to work in a team environment while handling individual responsibilities
• Interest in medical devices and the healthcare industry

Preferred Skills:

• Familiarity with ISO 13485, FDA Quality System Regulation (21 CFR Part 820)
• Understanding of supplier quality management processes
• Knowledge of statistical analysis methods
• Previous coursework in quality engineering or related areas

Duration and Schedule

• 6-month (January – June 2026) co-op position (flexible)
• Full-time (40 hours per week)
• On-site at our facility in Waltham, MA (minimum 3 days per week) for duration