Quality Engineer

Nuwellis, Inc.; Eden Prairie (MN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

HSA contributions

Dental & Vision

Life insurance

Disability insurance

PTO & holidays

401(k) match

Job summary

Nuwellis, Inc. is seeking a Quality Engineer to strengthen our Quality Management System and ensure our medical-device products meet QMSR, ISO 13485, and applicable regulatory requirements.

You will collaborate with Engineering, Manufacturing, Supplier Quality, and Operations on issues, changes, complaints, and validations. The role covers complaint handling, investigations, CAPA, supplier quality, audits, and documentation reviews, with a lean team requiring both strategic and hands-on quality

Qualifications

• Bachelor’s degree in engineering, science, or related field.
• At least 5 years of quality engineering/quality assurance experience in a medical-device manufacturing or R&D environment.
• Working knowledge of QMSR, ISO 13485, medical-device quality systems, design controls, and related standards.
• Experience with CAPA, complaints, nonconforming material, supplier quality, internal audits, risk management, product returns, or validation.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to manage multiple priorities and work well with cross-functional teams.

Responsibilities

• Support complaint handling, field return investigations, nonconforming material, CAPA, supplier quality, audits, validation activities.
• Review and approve quality documentation such as change requests, test methods, inspection criteria, specifications, and engineering records.
• Support product development, process improvements, risk management, validation, supplier qualification, and internal/external audit activities.
• Work across strategic and hands-on quality activities, independently managing complex tasks while supporting daily quality tasks and documentation.

Skills

Analytical skills

Documentation

Communication

Problem solving

Cross-functional teamwork

Statistical methods

Process capability

Quality data analysis

Validation

Education

Bachelor’s degree in engineering, science, or related field

Job description

Description

Nuwellis is not accepting resumes from 3rd party recruiters

Nuwellis is looking for a Quality Engineer to help support and strengthen our Quality Management System while ensuring our medical-device products and processes meet QMSR, ISO 13485, and other applicable regulatory requirements.

This role is a great fit for someone who enjoys solving problems, digging into data, working cross-functionally, and helping improve products that support patients and clinicians. You’ll partner with Engineering, Manufacturing, Supplier Quality, and Operations on quality issues, product changes, complaints, validations, supplier activities, and continuous improvement.

What You’ll Do

In this role, you will support complaint handling, field return investigations, nonconforming material, CAPA, supplier quality, audits, validation activities, and quality documentation. You’ll help evaluate product issues, identify root cause, support corrective actions, and ensure documentation is accurate, complete, and compliant.

You’ll also review and approve quality documentation such as change requests, test methods, inspection criteria, specifications, and engineering records. As part of the broader quality team, you’ll support product development, process improvements, risk management, validation, supplier qualification, and internal and external audit activities.

Because Nuwellis has a lean quality team, this role requires someone who is comfortable working across both strategic and hands-on quality activities. The ideal candidate will be able to independently manage complex quality work while also supporting day-to-day quality tasks, documentation, inspections, and follow-up activities as needed.

Requirements

What We’re Looking For

• Bachelor’s degree in engineering, science, or a related technical field; equivalent medical-device quality experience may be considered.
• At least 5 years of quality engineering or quality assurance experience in a medical-device manufacturing or R&D environment.
• Working knowledge of QMSR, ISO 13485, medical-device quality systems, design controls, and related standards.
• Experience with areas such as CAPA, complaints, nonconforming material, supplier quality, internal audits, risk management, product returns, or validation.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to manage multiple priorities and work well with cross-functional teams.

Preferred Experience

Experience with statistical methods, process capability, quality-data analysis, validation activities, supplier quality, and electromechanical medical devices is helpful.

Work Environment

This role is primarily performed in an office and manufacturing environment. It may involve sitting, standing, walking, computer work, light lifting up to 20 pounds, and use of required personal protective equipment in manufacturing, laboratory, or warehouse areas.

Nuwellis offers a comprehensive benefits package, including:

• Multiple health insurance plan options, including a high-deductible health plan with an annual company HSA contribution of $2,000 for individual coverage or $4,000 for family coverage
• Company contribution toward dental and vision coverage
• Employer-paid: life insurance of (up to 1X annual salary), paid short- and long-term disability
• PTO, floating holidays + 8 company holidays
• 401(k) plan with a 3% company match

Any offer of employment is contingent upon successful completion of a background check and drug screening.

Nuwellis is an Equal Opportunity Employer, including minority, female, disability and veteran applicants.