Quality Engineer

Role Overview

We’re looking for a Quality Engineer to take ownership of CAPA, quality investigations, and non‑conforming material processes in a regulated medical device environment. This is a hands‑on role where you’ll drive root cause analysis, implement meaningful improvements, and influence product quality across the lifecycle—not just on the manufacturing floor.

• Own CAPA processes from initiation through closure, including root cause analysis and effectiveness checks
• Lead quality investigations and resolve non‑conforming material (NCMRs)
• Identify gaps in quality systems and implement sustainable improvements
• Partner with Engineering, Regulatory, and Operations to resolve issues quickly and effectively
• Support Design Quality activities to ensure quality is built into products early
• Analyze data, document findings, and drive decisions using structured problem‑solving methods

Must‑Have

• 2–6+ years of Quality Engineering experience in medical device or regulated industry
• Hands‑on experience owning CAPA investigations end‑to‑end
• Experience with non‑conforming material (NCMRs) and quality investigations
• Strong problem‑solving and root cause analysis skills
• Ability to work independently and drive results with urgency

Nice‑to‑Have

• Experience in a CMO or small‑to‑mid‑sized med device company
• Exposure to Design Quality (beyond manufacturing)
• Experience in fast‑paced or high‑growth environments
• Familiarity with FDA/ISO standards

• True ownership of CAPA and quality systems—not just support
• Exposure across the full product lifecycle, including design quality
• High‑impact role in a growing organization where your work is visible
• Opportunity to build and improve processes, not just maintain them

This is a Permanent position based out of White Bear Lake, MN.

The pay range for this position is $45.00 - $60.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in White Bear Lake, MN.

This position is anticipated to close on Jul 2, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.