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Quality Engineer I

Chicago, IL

Who Are We?

Prolaio believes that continuous learning and collaboration can make the difference in how heart care can be administered. So, we are creating smarter ways to address heart disease and heart risks, by integrating a connected platform, enabled by smart data science to help patients access the care and attention that will inform better treatments and outcomes.

We envision a future where care teams and hospitals can be more effective, the health care system can be more efficient, and patients have a better care experience and more fulfilling lives.

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

What Will You Do?

The Overview

The Quality Engineer I is responsible to support production activities including Quality Control activities for components and suppliers, in-process and finished goods inspection and release, and the transfer of products/processes from Design to Production.

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.
  • Work with Design and Production teams to ensure the successful transfer of products and processes from Design to Production.
  • Support Complaint process by organizing investigations, if required, to ensure timely completion and documentation.
  • Perform monitoring and measurement activities, reporting regularly to the Director, QMS, and to Management via Management Review processes.

Why Prolaio?

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

Who You Are?

Experience and Education

  • Bachelor’s degree preferred, or at least 4 years of work experience in Medical Device or Pharmaceutical production environments
  • Experience with ISO 13485 and CFR Part 820

Technical Skills and Practice

  • Working knowledge of regulatory inspections/audits
  • CAPA experience is a plus

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

  • Competitive salary + performance bonus + equity
  • Medical, dental, and vision benefits with generous company contribution
  • Company-provided life insurance
  • 401(k) plan
  • 13 paid company holidays + vacation + sick time
  • Paid parental leave

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