Quality Engineer, MedTech | ISO 13485 & CAPA

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

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