Quality Specialist

What Will You Do?

The Quality Specialist is responsible for supporting production activities, including Quality Control activities for components and suppliers, as well as in‑process and finished goods inspection. The Quality Specialist also processes complaint records according to established procedures.

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

The Quality Specialist ensures that every component and finished product meets our quality standards and regulatory requirements.

• 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.
• 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.

• Competitive salary, performance bonus, and equity.
• Medical, dental, and vision plans with multiple options and strong company contributions.
• HSA, FSA, commuter benefits, and a $1,200 annual Lifestyle Spending Account to support wellness, commuting, family needs, and more.
• Generous paid time off, sick leave, and company holidays.
• Paid parental leave, caregiver leave, and support for growing families.
• Company‑paid life insurance and short‑ and long‑term disability coverage.
• 401(k) plan to help you build long‑term financial security.
• Easy access to telehealth and optional supplemental coverage for life’s unexpected moments.

• 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 knowledge 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.

As set forth in Prolaio’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.