About Cleerly
We’re Cleerly – a healthcare company based in Denver, Colorado and New York, New York 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 will enable rapid growth and continued support of our mission.
Cleerly is creating 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.
About the Team
The Quality and Regulatory team at Cleerly has the mission to empower team members to bring new, safe, and effective products to market and implement a quality foundation to support a patient-focused, innovative heart care organization.
About the Opportunity
The Quality Analyst will be expected to contribute to the day-to-day operations of the Quality and Regulatory department. A further opportunity is to learn the operations of Product Development, Quality Management, and Regulatory workings of a SaMD company to grow and increase the capabilities of the role.
Salary: $51,000 - $95,000*
*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.)
Responsibilities
- Implements and maintains effectiveness of the Quality Management System. This will include the documentation of employee training, product improvements, audits, and new product development.
- Primary responsibility is tracking documents and coordinating activities within Quality and Regulatory. This will include Document Control Support.
- May coordinate interactions between Quality, Engineering, Product Support, and Regulatory to ensure appropriate processes and changes are documented.
- Obtain a general understanding of the US (FDA) federal regulations and medical device requirements outside of the US.
- Develop a strong understanding of the development process and current products.
- Create and Maintain templates, forms, trackers, and metrics for products and processes.
Requirements
- BS in scientific discipline such as Biochemistry, Chemistry, Biology, or related discipline preferred. (New grad okay.)
- Experience using quality management systems software (e.g. Agile/Veeva) preferred.
- Equivalent education and experience may substitute for stated requirements.
- Strong computer literacy required (e.g. MS Office Suite, etc.)
- Strong technical writing and communication skills
- Ability to prioritize and execute tasks in a fast-paced environment.
- Willingness to take on new challenges and build on current skills.
- Ability to multi-task and be a self-starter.
- Ability to apply Good Documentation Practice (GDP) requirements as they relate to quality management systems.
- Experience with process complexity and progressing multiple priorities.
- Ability to work interdepartmentally effectively with good interpersonal skills.
OUR CORE VALUES:
- We strive to earn trust.
- We value and seek out differences.
- We obsess over client success.
- Our curiosity sparks change.
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.
