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.Reporting to the Senior Director of Technical Operations & Quality, The Head of Quality Assurance is responsible for overseeing all quality assurance activities at Eko, including ensuring compliance with US and International regulatory standards.
The role leads a team to develop, implement, and maintain quality systems across the product lifecycle with a primary focus on delivering high-quality devices that meet all safety and efficacy requirements.
As Head of Quality Assurance at Eko, You Will:
- Responsible for the implementation and reporting of the performance of the Quality Management System to the executive management team through Management Reviews.
- Responsible for CAPA, Nonconformity, and Internal Audits.
- Manage and lead a team of managers and individual contributors responsible for supplier quality and design assurance (hardware and software).
- Serve as an internal SME on European, Federal, and State regulations regarding design and manufacturing of medical devices. Provide guidance across the organization as needed to ensure cross-functional alignment.
- Lead the Quality team including hiring, training, coaching, and all other management responsibilities. Serve as a mentor and example for subordinate managers to ensure Eko leadership and culture standards are maintained.
- Maintain the company regulatory and QA training system, ensuring that the organization maintains compliance with necessary training requirements .
- Build and/or maintain procedures needed to meet regulatory requirements and business needs.
- Serve as the face of the organization and Interface with regulatory bodies (FDA, State FDB, and Notified Body) during external audits of the quality system.
- Proactively champions quality assurance issues in company-wide activities.
- Oversee and maintain the electronic Quality Management System.
- Oversee and lead the planning, scheduling, and completion of department projects in a manner consistent with corporate objectives.
- Procure and oversee outside vendors and consultants as required.
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
- Maintain complaint handling and vigilance reporting activities, compliant with US, EU and other global regulatory requirements.
- Conduct periodic Post-market surveillance activities for Eko’s medical devices, compliant with EU regulatory requirements
As Head of Quality Assurance at Eko, You Have:
- 10+ years of experience in quality assurance for a global medical device manufacturer
- Proven leadership experience in creating a culture of quality and building high-performing teams
- Strong familiarity with controls for Class 2 medical devices both hardware and SaMD through the entire product lifecycle
- Strong knowledge of international regulations and standards for Quality Management
- Excellent communication and collaboration skills
As Head of Quality Assurance at Eko, Nice to have:
- In-depth knowledge of good clinical practice for clinical investigations
- Experience writing or contributing to regulatory submissions
Benefits and Perks We Offer:
- Eko was recognized by “Great Place to Work” in 2020 and 2021
- 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
$180,000 - $200,000 a yearEko 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 proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives.
We celebrate diversity and are committed to building a diverse and inclusive team.Apply for this job
