Quality Assurance Engineer

Intellectt Inc; Minnesota; On-site; USD 85,000 - 120,000; Full time

Job summary

Intellectt Inc is seeking a Complaints Engineer with experience in medical devices, quality engineering, or post-market activities. The role focuses on investigating product complaints, identifying root causes, supporting CAPA, and improving product quality and safety.

You will review complaints and post-market data, lead technical investigations with X-Ray, FTIR, SEM, mentor junior investigators, and collaborate with Quality, R&D, Manufacturing, Regulatory, and other teams to drive continuous

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field.
• Experience in medical devices, quality engineering, complaints, CAPA, or post-market surveillance.
• Knowledge of ISO 13485, FDA QSR, and MDR requirements.
• Strong root cause analysis and problem-solving skills.
• Good understanding of statistical and data analysis techniques.
• Strong communication skills to work across teams.

Responsibilities

• Review and analyze product complaints, adverse events, and post-market quality data.
• Lead technical investigations and perform root cause analysis for product issues.
• Document investigation findings and maintain records within the quality system.
• Support or lead CAPA, NCEP, and other quality improvement activities.
• Work closely with Quality, R&D, Manufacturing, Regulatory, and other cross-functional teams.
• Analyze product performance trends and communicate findings to leadership teams.
• Support investigations using X-Ray, FTIR, SEM, and other laboratory equipment.
• Mentor junior investigators and help improve investigation processes.
• Identify opportunities for continuous improvement within post-market quality processes.

Skills

Root cause analysis

Problem-solving

Data analysis

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in engineering, science or related field

Tools

X-Ray

FTIR

SEM

Job description

We are looking for a Complaints Engineer with experience in medical devices, quality engineering, or post-market activities. This role will focus on investigating product complaints, identifying root causes, supporting CAPA activities, and improving product quality and safety.

Responsibilities:

Review and analyze product complaints, adverse events, and post-market quality data.

Lead technical investigations and perform root cause analysis for product issues.

Document investigation findings and maintain accurate records within the quality system.

Support or lead CAPA, NCEP, and other quality improvement activities.

Work closely with Quality, R&D, Manufacturing, Regulatory, and other cross-functional teams.

Analyze product performance trends and communicate findings to technical and leadership teams.

Support investigations using tools such as X-Ray, FTIR, SEM, and other laboratory equipment.

Mentor junior investigators and help improve investigation processes.

Identify opportunities for continuous improvement within post-market quality processes.

Requirements:

Bachelor’s degree in engineering, Science, or a related technical field.

Experience in medical devices, quality engineering, complaints, CAPA, or post-market surveillance.

Knowledge of ISO 13485, FDA QSR, and MDR requirements.

Strong root cause analysis and problem-solving skills.

Good understanding of statistical and data analysis techniques.

Strong communication skills with the ability to work effectively across multiple teams.

Preferred:

Experience with Interventional Cardiology or other complex medical devices.

Hands-on experience with analytical/investigative equipment.

Experience leading technical investigations and presenting findings to leadership.