Senior QA Specialist- Medical Devices

Magenta is a medical device company developing the world’s smallest heart pump, meant to provide minimally-invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multi-disciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms and state-of-the-art catheter fabrication techniques.

We are looking for the best people possible who can help us propel the Elevate™ System forward and save more lives.

We are looking for an Experienced Quality Assurance Specialist to join our QA Operations group and support the variety of activities related to QA Operations, such as:

• Lead QA Operations activities with regards to verifications/validations for an FDA reviewed complex, multidisciplinary, active investigational device.
• Leading and performing the ECO process from risk analysis through protocol approval.
• Verification execution and analysis to FDA review-ready final reports.
• Guiding R&D and Engineering team efforts on IQ/OQ/PV activities. 

Qualifications

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
• 5+ years of relevant experience in the medical device industry
• Previous experience with medical device verification/validations, ECOs, medical device statistics
• Working knowledge of medical device international standards.
• Ability to work independently with minimal work direction and in a cross-functional team environment.
• Fluent in English with excellent writing skills
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Ability to effectively communicate written and verbally.
• Ability to manage time effectively to ensure timely completion of tasks.
• Detail oriented