Quality Specialist

Who Are We?

Prolaio believes that continuous learning and collaboration can make a significant difference in how heart care is administered. We are creating smarter ways to address heart disease and heart risks by uniting patients care teams and researchers on a secure technology-enabled platform that drives clinical innovation and offers a path towards better patient outcomes.

This is precision cardiology and we know it’s within reach.

What Will You Do?

The Overview

The Quality Specialist is responsible for supporting production activities including Quality Control activities for components and suppliers and in-process and finished goods inspection. The Quality Specialist is also responsible for processing Complaint records according to established procedures.

This role reports to the Director Quality Management Systems working on the Regulatory Quality and Clinical Development Operations Team. This is a hybrid role based in our Chicago office.

The Specifics

• Ensure specifications for components are complete and accurate prior to acceptance activities.
• Ensure suppliers for components and services that may impact product quality are formally qualified and documented as such.
• Perform quality inspections of finished goods and device history records and release goods if accepted.
• Support environmental monitoring activities.
• Support Complaint process by organizing investigations if required to ensure timely completion and documentation.
• Comply with the expectations of the Quality Management System (QMS) including Biosketch forms job descriptions training etc.

Why Prolaio?

• Impactful Work: You will join in the fight against heart failure (HF) and hypertrophic cardiomyopathy (HCM) with the goal of extending and saving the lives of our patients while also being at the forefront of changing the healthcare industry through technology.
• Innovative Environment: You will be part of an organization doing something that’s never been done before.
• Professional Growth: You will join a growing team and have a substantial impact on our daily and future operations with the opportunity to continuously learn and grow.
• Collaborative Team: You will be part of a team of collaborative curious and committed individuals focused on the collective good inclusiveness scientific excellence and advancing digital health for cardiology.

Who You Are?

Experience and Education

• Bachelor’s degree preferred or at least 2 years of work experience in Medical Device or Pharmaceutical production environments
• Experience with ISO 13485 and CFR Part 820
• Working knolwedge of regulatory inspections/audits 

Additional Qualifications

• Passionate about what you do and excited about contributing your skills to enable better healthcare through technology.
• Humble kind and keen to receive and act on feedback excited to help your teammates and celebrates the success of your team.
• Can work independently with minimal supervision and proactively identify and mitigate future challenges.
• Are a critical thinker and creative problem solver who can collaborate effectively with individuals internally and externally.
• Eager to learn and grow and is not afraid of challenging and complex work.

Company Benefits

• Meaningful Compensation: Competitive salary performance bonus and equity so you can share in what we build.
• Great Health Coverage: Medical dental and vision plans with multiple options and strong company contributions.
• Flexible Spending Perks: HSA FSA commuter benefits and a $1200 annual Lifestyle Spending Account to support wellness commuting family needs and more.
• Time to Recharge: Generous paid time off sick leave and company holidays.
• Family-First Benefits: Paid parental leave caregiver leave and support for growing families.
• Security & Peace of Mind: Company-paid life insurance and short- and long-term disability coverage.
• Plan for the Future: 401(k) plan to help you build long-term financial security.
• Care When You Need It: Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

Starting Salary is at $60000.00 (Exact Compensation may vary based on skills experience and location)

What We Do

Prolaio is a clinical intelligence company dedicated to unlocking continuous predictive and shareable heart data to liberate patients from hospital-based reactive care and accelerate every new therapy. The company was created by cardiologists cardiovascular practitioners and data scientists specifically to address the world’s number one cause of death — cardiovascular disease. By combining scientific rigor with cutting‑edge technology Prolaio aims to transform real‑world heart data into faster discovery today and precision care for functional cures tomorrow.

Why Work With Us

Kardigan and Prolaio were both founded to challenge the status quo in cardiology. If we have any shot at radically reducing the time and cost to develop meaningful new medicines and provide better healthcare access and outcomes for patients we need to fundamentally embrace real-world data and AI-based tools in a way that is fully integrated across

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