Complaints Engineer / Quality Engineer

Intellectt Inc; Arden Hills (MN); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Benefits eligibility

Job summary

Intellectt Inc is seeking a Complaints Engineer/QE to lead post-market complaints, technical investigations, CAPA/NCEP, and root cause analysis for Interventional Cardiology devices in Minnesota. You will analyze complaints, guide root-cause investigations, document findings in the quality system, and own CAPA/NCEP activities to drive timely resolutions.

This role requires a Bachelor's degree in engineering or sciences, knowledge of ISO 13485/FDA QSR, and strong analytical and cross-functional

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical field.
• Experience with complaints, CAPA, root cause analysis, or post-market quality in medical devices.
• Knowledge of ISO 13485, FDA QSR, and MDR preferred.
• Strong analytical, statistical, problem-solving, and cross-functional communication skills.

Responsibilities

• Analyze complaints and adverse events to identify product safety and quality issues.
• Lead technical/root cause investigations and document findings in the quality system.
• Own CAPA/NCEP activities and drive timely resolution.
• Use investigative tools such as X-Ray, FTIR, and SEM.
• Present product performance findings to leadership and design teams.
• Mentor investigators and support continuous improvement across Post Market teams.

Skills

Analytical skills

Root cause analysis

Cross-functional communication

Education

Bachelor’s degree in Engineering, Science, or related technical field

Tools

X-Ray

FTIR

SEM

Job description

Seeking a Complaints Engineer/QE to lead post-market complaints, technical investigations, CAPA/NCEP, and root cause analysis for Interventional Cardiology devices.

Key Responsibilities:

• Analyze complaints and adverse events to identify product safety and quality issues.
• Lead technical/root cause investigations and document findings in the quality system.
• Own CAPA/NCEP activities and drive timely resolution.
• Use investigative tools such as X-Ray, FTIR, and SEM.
• Present product performance findings to leadership and design teams.
• Mentor investigators and support continuous improvement across Post Market teams.

Required Qualifications:

• Bachelor’s degree in Engineering, Science, or related technical field.
• Experience with complaints, CAPA, root cause analysis, or post-market quality in medical devices.
• Knowledge of ISO 13485, FDA QSR, and MDR preferred.
• Strong analytical, statistical, problem-solving, and cross-functional communication skills.

Industry: Medical Devices – Interventional Cardiology

Benefits:

• Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.