What are the responsibilities and job description for the Quality Engineer Co-Op Jun-Dec2026 position at Paragonix Technologies, Inc.?
About Paragonix Technologies
Paragonix Technologies is a leading innovator in organ transportation and preservation systems, dedicated to improving transplant outcomes through state-of-the-art technology. Our mission is to enhance the quality and safety of donated organs during transport, ultimately saving more lives through successful transplantation.
Position Overview
We are seeking a motivated Quality Engineering 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.
Responsibilities
- Support the documentation and maintenance of quality records in compliance with FDA and EU regulations
- Assist with supplier quality management activities, including supplier evaluation and monitoring
- Assist in post-market surveillance, including device failure investigation and follow-up corrective actions
- Help coordinate incoming inspections of finished products
- Participate in internal quality audits and help prepare for external regulatory inspections
- Contribute to risk management activities
- Help track and analyze quality metrics and contribute to continuous improvement initiatives
- Assist with validation and verification testing of product design changes
- Support document control processes for technical documentation
- Collaborate with cross-functional teams including R&D, Operations, and Regulatory Affairs
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 & Schedule
- 6-month co-op position (flexible)
- Full-time (40 hours per week)
- On-site at our facility in Waltham, MA