Quality Specialist

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.

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.

• 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.

• 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.

• 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 

• 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.