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Prolaio

Quality Engineer I

Chicago, ILentryAdded today

About this role

Prolaio, a precision cardiology technology company, seeks a Quality Engineer I to support production quality control, supplier qualification, and product/process transfers in a hybrid Chicago role. You'll ensure regulatory compliance, conduct inspections, and partner with cross-functional teams to maintain quality standards for medical devices.

What you'll do

  • Validate component specifications and ensure supplier qualification for quality-impacting materials and services
  • Perform quality inspections of finished goods and device history records, authorizing product release
  • Support environmental monitoring activities and conduct monitoring/measurement reporting to leadership
  • Facilitate product and process transfers from Design to Production teams
  • Organize and document complaint investigations and corrective actions
  • Maintain compliance with ISO 13485 and CFR Part 820 regulatory requirements

What they're looking for

  • ISO 13485 and CFR Part 820 knowledge
  • Quality control and inspection protocols
  • Supplier qualification and management
  • Regulatory audits and inspections familiarity
  • CAPA (Corrective and Preventive Action) experience
  • Medical device or pharmaceutical production background
  • Critical thinking and problem-solving
  • Cross-functional collaboration

Benefits

  • Competitive salary with performance bonus and equity
  • Medical, dental, and vision coverage with substantial employer contribution
  • Company-provided life insurance
  • 401(k) retirement plan
  • 13 paid holidays plus vacation and sick time
  • Paid parental leave
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Prolaio

Prolaio builds a mobile application that connects patients, care teams, and researchers to support heart care management. The company is hiring Android Developers to enhance the app through feature development, performance optimization, and API integration.

View all jobs at Prolaio

Likely interview questions

  • Walk us through your experience with ISO 13485 and CFR Part 820 compliance in a production environment.
  • Describe a time you identified a quality issue during supplier evaluation or component inspection—how did you handle it?
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