Sr. Quality Engineer

Nuwellis is seeking a Senior Quality Engineer ready to take the next step in their career through broader responsibility, meaningful autonomy, and hands-on work improving medical devices that support patients and clinicians. As part of our lean team in Eden Prairie, Minnesota, you’ll work closely with the Director of Quality and Regulatory Affairs and cross-functional partners to solve quality challenges across new product development, manufacturing, and post-market activities.

This position requires regular on-site presence as an essential function of the role.

What You’ll Do

• Complaint Management — Improve complaint intake and processing, conduct returned-product investigations with cross-functional partners, contribute findings to risk-management activities, and analyze complaint trends to identify opportunities for improvement.
• New Product Development — Provide quality support for development planning, specification development, verification and validation testing, and product documentation.
• CAPA and Supplier Quality — Manage corrective and preventive action (CAPA) records, support nonconforming material handling, and participate in supplier quality activities.
• QMS Management — Review and revise procedures, support audits, and contribute to change control activities.
• Manufacturing Quality Support — Help ensure manufacturing processes and resulting products meet applicable specifications and quality requirements.

This opportunity is well suited to a quality engineer with a solid foundation who enjoys problem-solving, data analysis, and seeing improvements through to implementation. You’ll balance hands-on quality work with broader improvement initiatives, manage competing priorities, and exercise independent judgment within your areas of responsibility. You’ll build on your existing strengths while expanding your experience across the product lifecycle, with opportunities to take on additional ownership as your experience grows.