Quality Engineer

Quality Engineer - New Product Introduction

We're looking for a Quality Engineer who thrives on solving complex problems, driving meaningful improvements, and influencing product quality from development through commercialization. In this role, you'll take ownership of critical quality initiatives, partner closely with Engineering and Regulatory teams, and help ensure safe, effective medical device products reach patients. This is an exciting opportunity for someone who enjoys working in a growing, innovative environment where they can make a visible impact, improve quality systems, and help shape processes as the organization continues to scale.

As our Quality Engineer, you'll play a key role in maintaining and improving the effectiveness of our Quality Management System while partnering with cross-functional teams to investigate issues, drive improvements, and support product quality.

• Lead corrective and preventive action (CAPA) activities from investigation through implementation and closure.
• Conduct root cause investigations and partner with stakeholders to identify effective corrective actions.
• Manage non-conforming material reports (NCMRs), ensuring timely review, disposition, and resolution.
• Support design quality activities throughout the product lifecycle, helping ensure compliance and product reliability.
• Collaborate with Engineering, Regulatory Affairs, Operations, and Manufacturing partners to address quality issues and drive continuous improvement.
• Identify opportunities to strengthen quality processes, improve efficiency, and reduce risk.
• Support quality system initiatives and help maintain compliance with applicable regulations and standards.
• Analyze quality trends and data to proactively identify potential issues and improvement opportunities.
• Contribute to a culture of quality, accountability, and continuous learning across the organization.

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• 2+ years of experience in Quality Engineering within medical devices, biotech, life sciences, or another regulated industry.
• Experience managing CAPAs and quality investigations.
• Experience with nonconformance management and quality systems.
• Strong root cause analysis and problem-solving skills.
• Ability to independently manage projects while collaborating effectively across teams.
• Excellent communication skills and the ability to work with technical and non-technical stakeholders.
• Working knowledge of FDA, ISO 13485, or other regulated quality environments.

• Experience supporting design quality activities or product development programs.
• Experience in a startup, growth-stage company, CMO environment, or small-to-mid-sized medical device organization.
• Experience improving or building quality processes and systems.
• Familiarity with risk management and product lifecycle quality activities.

• Opportunity to own impactful quality initiatives and influence product quality decisions.
• Highly collaborative environment with direct interaction across Engineering, Quality, Regulatory, and Operations.
• Exposure to both technical quality work and strategic process improvement efforts.
• Ability to grow your career within a rapidly evolving medical device organization.
• Mission-driven team focused on improving patient outcomes.
• Potential eligibility for equity participation upon full-time conversion, subject to company policies.

Job Type &

Location:

This is a permanent position based out of Saint Paul, MN.

Pay and Benefits:

The pay range for this position is $45.00 - $60.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: 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).

Workplace Type:
This is a fully onsite position in Saint Paul, MN.

Final date to receive applications:
This position is anticipated to close on Aug 21, 2026.