Salary :
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About Avive:
Avive Solutions, Inc. (https://avive.life) is a growth stage Automated External Defibrillator (AED) company with a connected response system that is rapidly gaining market share. We are a mission driven team that is quite literally saving lives. Sudden Cardiac Arrest (SCA) is a leading cause of death in the United States, and we are on a mission to change that! We are a dynamic organization that builds elegant, creative solutions to solve complex problems. Ultimately, our mission is for all cardiac arrest victims to have rapid access to life-saving defibrillation.
Avive is taking a fresh approach to addressing this decades-old problem by innovating AED technology, coupled with a first-of-its-kind software platform solution to enable a quicker and more streamlined response to SCA emergencies. We believe that this unique combination of deploying advanced – yet still accessible – hardware, and software, has the potential to revolutionize out-of-hospital cardiac arrest response and massively impact SCA survival rates.
Check out this short video that shows a glimpse of how our team is working to re-think cardiac arrest response and save lives! https://www.youtube.com/watch?v=2p4zfOWo62E
Learn more about working at Avive: https://avive.life/careers/
About the Role:
This position will support the Quality Assurance team in maintaining and improving the Quality Management System (QMS) in compliance with applicable medical device regulations, including 21 CFR Part 820 and ISO 13485. This is a summer internship that will last approximately 10 weeks.
What you'll do:
- Support the maintenance and continuous improvement of the Quality Management System (QMS) by ensuring records, documentation, and quality files are accurate, and complete
- Contribute to training program administration by helping ensure training plans are current and employees are meeting compliance requirements.
- Assist in supplier quality activities, including maintaining supplier documentation and supporting the collection and routing of supplier change notifications and assessment records.
- Analyze supplier inspection data and update inspection plans
- Support nonconformance and complaints root cause investigation activities.
- Contribute to Corrective and Preventive Action (CAPA) process by organizing and analyzing data, and outlining improvement actions.
Required Skills & Experience:
- In the process of obtaining a bachelor’s or master’s degree in an engineering field (e.g. Electrical, Mechanical Engineering, or Biomedical Engineering).
- Strong analytical and problem-solving skills with excellent attention to detail
- Strong understanding of engineering principles
- Strong interpersonal, and communication skills
- [Preferred] Technical knowledge of electromechanical systems and software medical devices
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