Quality Engineer (Medtech)

TL;DR

Quality Engineer (Medtech): Supporting quality systems and processes compliant with FDA and ISO standards for hearing instrument manufacturing with an accent on root cause analysis, CAPA, and risk management. Focus on driving continuous improvement, managing change orders, and ensuring product safety and performance through statistical process control.

Location: Must be based in Shakopee, MN (Onsite)

Salary: $80,000–$95,000/yr

Company

GN is a global leader in intelligent hearing, audio, video, and gaming solutions, dedicated to enhancing human senses through innovative technology.

What you will do

• Develop and maintain quality system procedures compliant with FDA and ISO requirements.
• Conduct root cause investigations and manage CAPA action planning and verification.
• Review and approve Engineering and Manufacturing Change Orders.
• Design and perform quality methods including FMEA and statistical process control.
• Monitor incoming, in-process, and shipped product quality to identify trends and drive improvements.
• Collaborate cross-functionally with manufacturing, supply chain, and engineering to resolve quality issues.

Requirements

• Bachelor’s Degree in Engineering or equivalent experience.
• 2+ years of related work experience in Quality Engineering, Quality Control, or CAPA.
• Strong problem-solving, organizational, and communication skills.
• Ability to work onsite in a manufacturing and office environment.
• Must be eligible to work in the United States.

Nice to have

• Experience in Medical Device Manufacturing.
• Knowledge of ISO 13485 standards.

Culture & Benefits

• Competitive salary with discretionary bonus eligibility.
• Comprehensive benefits package including 401(k) with company match.
• Paid Parental Leave and transition back-to-work benefits.
• Company HSA contributions.
• Generous PTO and paid holidays.
• Employee discounts on GN Group products.