Sr./Director, Quality Assurance

About Cleerly

We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. 

Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. 

At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. 

About the Team

The mission of the Regulatory and Quality Affairs team is to empower Cleerly to bring new, safe, and effective products to market and implement a quality foundation to support a patient-focused, innovative heart care organization. Cleerly is building a best in class Regulatory and Quality team in order to establish Cleerly as a leader in SaMD and Healthcare AI. Cleerly products and services are being developed at the leading edge of AI software medical devices. We are seeking subject matter experts to join our growing team.

About the Opportunity

We are a growing startup company focused on developing and distributing machine learning (artificial intelligence) solutions for medical applications. The Senior Director of Quality Assurance plays a pivotal role in driving Quality and Regulatory strategy and ensuring compliance with global regulatory requirements. You will build, manage, and lead a talented team and collaborate cross-functionally to advance our innovative cardiovascular imaging products, ensuring a safe and effective device/software.
You will join a team that delivers at high frequency by using and creating the latest technologies, interacting constantly with your team, and communicating daily with the product team. You will also work daily with data scientists and medical doctors, who will help integrate software solutions with healthcare systems, all in an environment conducive to productivity, brainstorming, and close collaboration across teams, with each team member being an integral part of the creative process.

Salary: $210k - $270k

 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). We hire employees anywhere within the United States and account for geography when determining base salary.

Responsibilities

• Responsible for product quality, safety and Regulatory Compliance.
• Lead the continuous improvement of the Cleerly QMS per ISO 13485:2016, MDSAP, EU MDR, 21CFR820, 21CFR803, and 21CFR801.
• Lead and manage all internal and external audits (i.e., Registrar, Customer, FDA, other regulatory agencies).
• Develop and execute Quality Strategic Plans to ensure the QMS is suitable for geo expansion in target geographies.
• Define and influence rapid transformation of ideas to requirements to products.
• Actively identify improvements to the processes within the QMS to ensure compliance and quality (Continuous Improvement).
• Implement and maintain a risk management process compliant with ISO 14971.
• Implement and maintain a Software Lifecycle process in compliance with IEC 62304 for medical device software
• Provide expertise and leadership around design controls, ensuring that all designs are validated and have the applicable DHF, DMR, and DHR.
• Lead and mentor a high-performing Quality Assurance team, providing guidance, coaching, and development opportunities to team members to foster growth and ensure quality excellence.
• Collaborate closely with cross-functional teams to integrate Quality requirements into product development activities. Act as a quality representative in cross-functional meetings and project teams.
• Effectively partner with R&D/Engineering to define work and solve technical issues.
• Ensure successful development, verification, validation, and transfer of design.
• Chair the CRB for complaints and Corrective and Preventative Actions to ensure timely and effective closure.
• Provide diligent and fact-based communication to the Executive Management Team and peers.
• Assess resource needs to align the required level of quality support provided when needed with suitable competencies.
• Identify Quality Initiatives to address field Quality Issues and define prevention mechanisms for future development projects.
• Work with RA on post-market and pre-market activities around the areas of Design Controls, Supplier Controls, Risk Management, Test Methods, Safety Assurance, V&V, Cybersecurity, and Human Factors

Requirements

• Education: B.S. or higher degree in Engineering or a related discipline.
• ASQ Certified Quality Engineer is a plus.
• Lean/Six Sigma Black Belt (Experience Preferred).
• Certified Lead Auditor for ISO 13485 or MDSAP.
• 15+ years of medical device industry experience or regulated industry.
• Strong leadership and managerial skills with a minimum of 5 years of experience in leading and developing teams.
• Experience in multiple site leadership.
• Experience in supporting 3rd party audits and inspections (FDA, Notified Bodies, MDSAP, etc.).
• Strong understanding and knowledge of 21 CFR 820, IEC 62304, ISO 62366-1, ISO 13485, and ISO 14971.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and influence stakeholders.

Skills & Abilities

• Excellent command of the English language; ability to draft and revise documents with consistency of format and language; Mac and Google apps proficient.
• Strong technical presentation skills.
• Ability to remain organized and productive in a fast-paced work environment with competing priorities.
• Be a self-starter, work independently, diligently, and efficiently on assigned tasks and projects.
• Collaborate seamlessly with colleagues from other technical teams.

Working at Cleerly takes HEART. Discover our Core Values:

• H: Humility- be a servant leader
• E: Excellence- deliver world-changing results
• A: Accountability- do what you say; expect the same from others
• R: Remarkable- inspire & innovate with impact
• T: Teamwork- together we win

Why you should apply:

• PURPOSE: Cleerly’s purpose is to create a world without heart attacks. With our new paradigm for precision heart care, we will leave big footprints in the sands of time. Help us make that a reality!
• GROWTH: We prioritize learning and growth. As a rapid growth company, there is always space for new challenges and responsibilities.
• OWNERSHIP: Everyone on the team contributes to our success, so everyone has equity in the company through our employee stock option incentive plan.
• BENEFITS: Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs. Along with stock options and a 401(k) match program that helps you invest in the future, Cleerly also offers company wide holidays, a winter break, as well as a self-managed PTO policy. Additional benefits include, wellness, home office and learning & development stipends and parental leave benefits for new parents.

Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences.

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER.  We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

Job duties, activities and responsibilities are subject to change by our company.

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