Quality Analyst (12 months contract)

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 $125M 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.

As a Quality Analyst at Eko, You Will:

• Management (review, approval and archiving) of manufacturing batch records/ DHRs using eQMS, working with Eko Health Technical Operations and an oversea Contract Manufacturer.
• Receive and process medical device complaints and vigilance reports following US FDA and EU MDR regulations. Experience with other MDSAP regions is also highly preferred.
• Manage Eko Health’s Corrective and Preventive Actions (CAPA). Generate regular CAPA status report updates, collaborate with CAPA owners for action items, chair monthly CAPA status meetings.
• Working with EU MDR entities, such as Competent Authority, Notified Body, Importer/Distribution and Authorized Representative
• Administer Eko Health’s EUDAMED, FDA GUDID and GTIN-related databases
• Writes EU-MDR Post Market Activities documentation, such as PMSP, PSUR and Trend Reports a plus
• Assist Head of Quality with other general QMS administrative tasks, such as generating QMS health dashboard updates, eQMS training assignments

As a Quality Analyst at Eko, You Have:

• Minimum 3 years demonstrated understanding and working experience with complaint handling within Medical Device QMS (ISO13485:2016)
• Working experience with an electronic Quality Management System (eQMS). Experience as eQMS superuser/administrator highly preferred
• Attention to detail and diligence with regular scheduled (weekly, monthly, yearly) tasks highly essential
• Local (within 50 miles of the Eko Health,Inc office at Emeryville, CA) and able to work in-person minimum one day per week.
• 2-5 years demonstrated understanding and working experience with Regulation (EU) 2017/745 EU MDR will be positively regarded
• Demonstrated ability to write EU MDR Post Market Activities documentation will be positively regarded
• Relevant working experience with Software as Medical Device (SAMD) and medical database products will be positively regarded
• Relevant working experience with regulations of other MDSAP, UKCA and EMEA regions will be positively regarded 

Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others.

Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI-powered analysis. Its FDA cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in-person, and through telehealth. The company is headquartered in Oakland, California and privately-held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others.