Product Quality Assurance Engineer

Eko is a digital health company that provides healthcare professionals with industry-leading digital tools to hear and understand their patients' hearts and lungs. The Product Quality Assurance Engineer will lead efforts to ensure Eko's products are designed and developed in compliance with procedures and industry standards, regulations, and best practices.

Requirements

• Bachelor's degree in engineering, Quality, Life Sciences, or a related field (or equivalent experience)
• 5+ years of experience in a Quality Assurance/systems role within a regulated industry
• In-depth knowledge of quality systems, ISO standards (such as ISO 13485), FDA regulations, ICH Quality, CRFs, and other relevant quality frameworks
• Experience in implementing state-of-the-art medical device standards, including ISO 13485 (Quality Management), ISO 14971 (Risk Management), IEC 60601 (Electrical Safety), IEC 62304 (Software Lifecycle), IEC 81001-5-1 (Health Software Cybersecurity), ISO 14155 (Clinical Investigation of Medical Devices), and compliance with 21 CFR 820 and EU MDR

Benefits

• Paid-time off
• Medical/Dental/Vision, Disability + Life Insurance
• One Medical membership
• Parental Leave
• 401k Matching
• Work from home equipment stipend
• Flexible schedules
• Wellness programs (Wellness Wednesdays, Time off)
• Wellness perks (Headspace, Ginger, Aaptiv, Physera)
• Learning and Development stipend