Quality Assurance Engineer

About the Company

Magenta Medical is a Class III 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, materials science, electrical engineering, software, algorithms, and state-of-the-art catheter fabrication techniques. As we approach commercial manufacturing and scale-up, we're expanding our Operations, Engineering, Clinical Support, R&D, and Marketing teams. We are looking for the best people possible who can help us advance the Elevate™ System to the market and help us save more lives.

About the Role

We are seeking Quality Assurance Engineer to join our QA Operations team and support a variety of activities related to QA Operations.

Responsibilities

• Oversight of reception of components and Receiving Inspection activities.
• Investigation of non-conforming material (MRB) across the company.
• DHR and additional manufacturing records review and approval.
• COC Preparation and final product release.
• Ongoing monitoring of production workstations providing feedback regarding compliance.
• Oversight of manufacturing activities, training and qualification processes.

Qualifications

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science - Must.
• 2+ years of relevant experience in the medical device industry - Must.

Required Skills

• Working knowledge of medical device international standards - Must.
• Ability to work independently with minimal work direction and in a cross-functional team environment - Must.
• Fluent in English with excellent writing skills, effective written and verbal communication skills - Must.
• Excellent computer skills, including a working knowledge of Microsoft Office applications - Must.
• Strong time management abilities to ensure timely task completion - Must.
• Detail-oriented.