Senior Quality Engineer (Temporary to Potential FT Hire)

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 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 Senior Quality Engineer will be expected to contribute to maintaining the Quality Management System of Labs 2.0 with an emphasis in Complaints and CAPA’s.    

This is a Temporary position (3-4 months) with an opportunity to convert to full-time employment. The hourly rate will be $55-65 per hour, working full-time hours. 

Responsibilities

• Implements and maintains effectiveness of the Quality Management System.  This will include the responsibility for Quality documents including Standard Operating Procedures, Work Instructions and other records as required.
• Integrate Analysis activities regarding product improvements, audits, and new product development.
• Tracking, documenting, and coordinating activities within Quality that affect repeatability and reproducibility.
• Implement and remediate processes for complaints to ensure defendable compliance to 21CFR820, and MDSAP.
• Participate and lead Risk Analysis initiatives (Health Hazard Evaluations, Health Risk Assessments, Risk Management File updates)
• Remediate the Corrective Action Preventative Action process and system to ensure full defendable compliance to the 21CFR820 and MDSAP.
• Document processes and procedures as required
• Perform Internal Audits
• Support External Audits (FDA, MDSAP, ISO etc)
• Coordinates the interactions between Quality, Engineering, Product Support, and Regulatory to ensure appropriate processes and changes are created, reviewed, and documented.

Requirements

• BS in scientific discipline such as Biochemistry, Chemistry, Biology, or related discipline preferred. 
• Minimum 5 years of Quality Engineering experience in medical device, biotech, or pharmaceutical industry with bachelor’s degree. 
• Must have a good understanding of the US (FDA) federal regulations and medical device requirements outside of the US.
• Having startup experience is preferred
• Experience using quality management systems software (e.g. Agile/Veeva) preferred.
• Strong English Language skills are essential.
• Strong computer literacy required (e.g. MS Office Suite, etc.)
• Strong technical writing and communication skills
• Ability to apply Good Documentation Practice (GDP) requirements as they relate to quality management systems.
• Experience with process control, gauge R&R, and other Quality tools (5 Whys, Fishbone, CAPA processes, etc.)
• Familiarity with MDR and FDA level audits.
• Ability to work interdepartmentally effectively with good interpersonal skills.

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