At Eko, we’re dedicated to providing healthcare professionals with industry leading digital tools to hear and understand their patients’ hearts and lungs. With our platform, clinicians can detect cardiopulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible.
With over $165M in funding from partners like 3M and the Mayo Clinic, Eko has become one of the fastest growing digital health companies, doubling our customer base in the last year to over 500,000 clinicians across 4,000 U.S. hospitals. We’ve built a tremendously talented, diverse, and mission driven team and are proud to be certified as a Great Place to Work®. Together we are committed to investing in each other and our mission to ensure all patients have access to high quality care.
The Product Quality Assurance Engineer will lead efforts to ensure Eko’s products are designed and developed is in compliance with procedures and industry standards, regulations and best practices.
In this role the Product Quality Assurance Engineer will be responsible for following and maintaining our Quality Management System processes to support the development of products in compliance with international and US medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key design control, risk management, and change control deliverables for new product development and current on-market products. The role will partner with cross-functional groups to ensure audit-readiness across the quality management system including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval.
The ideal candidate has worked in a medical device industry regulated by ISO 13485 and 21 CFR 820 and includes products containing both hardware and software aspects.
This is a hybrid role with required onsite presence on Tue/Wed/Thu.