Quality Engineer

Quality Engineer - Medical Device Complaints & Product Performance

Location: Arden Hills, MN (Hybrid - Onsite Tuesday, Wednesday & Thursday)

Pay Rate: $37.00/hour

We are seeking a Quality Engineer I to support post-market product performance and complaint investigations for a leading medical device organization. This hybrid engineering role focuses on analyzing product complaints, monitoring device performance trends, supporting risk management activities, and collaborating with cross-functional teams to improve patient safety and product quality.

Key responsibilities include reviewing returned product analysis, performing complaint investigations, analyzing post-market surveillance data, supporting CAPA and risk management activities, and communicating product performance findings to internal stakeholders. The Quality Engineer will also assist with data analysis, statistical reporting, quality system processes, and technical documentation within a regulated medical device environment.

The ideal candidate will have an electrical engineering background, strong analytical skills, and experience working within quality systems and regulated manufacturing environments.

Qualifications

• Bachelor's degree in Electrical Engineering or Biomedical Engineering
• 1-3 years of engineering or quality experience
• Strong electrical engineering background required
• Experience with complaint investigations, product analysis, or quality systems preferred
• Knowledge of FDA regulations, CAPA, risk management, and medical device quality systems preferred
• Strong technical writing, communication, and data analysis skills
• Ability to manage multiple projects and work independently in a fast-paced environment

Additional Information

• Hybrid schedule: 3 days onsite weekly
• Must be authorized to work in the U.S. without sponsorship now or in the future

If you are looking to grow your career in medical device quality engineering and product performance analysis, click "Apply Now".

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

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