Senior Quality Assurance Engineer (Medical Devices)

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

We seek the best people to help us advance the Elevate™ System and save more lives.

We are currently looking to hire 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 about verifications/validations for an FDA-reviewed complex, multidisciplinary, active investigational device.
• Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.
• Verification, execution, and analysis of reposts until FDA-ready.
• Guide the R&D and Engineering teams 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 direction and in a cross-functional team environment.
• Fluent in English with excellent writing skills and practical written and verbal communication skills.
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Strong time management abilities to ensure timely task completion.
• Detail-oriented.