Complaints Engineer

Job Title: Complaints Engineer / Quality Engineer Post Market
Location: Arden Hills, MN
Pay $30-35/hr on W2
Industry: Medical Devices Interventional Cardiology

Job Description:

We are seeking a Complaints Engineer / Quality Engineer to support post-market quality activities for Interventional Cardiology medical devices. This role will lead technical investigations, analyze complaint and adverse event data, and drive root cause analysis and corrective actions to address product safety and quality issues.

Key Responsibilities:

• Analyze post-market complaints, adverse events, and product performance data to identify emerging safety and quality trends.
• Lead technical investigations and root cause analysis for escalated product issues.
• Document investigation findings and conclusions in the quality management system.
• Own and manage CAPA and NCEP activities through timely closure.
• Use investigative equipment and techniques, including X-Ray, Fourier Transform Infrared Spectroscopy (FTIR), and Scanning Electron Microscopy (SEM).
• Present investigation results and product performance insights to leadership, design teams, and cross-functional stakeholders.
• Support preparation of product performance reports.
• Mentor product investigators and drive continuous improvement across local and global Post Market teams.

Required Qualifications:

• Bachelor's degree in Engineering, Science, or a related technical field.
• Experience in medical device complaints, technical investigations, CAPA, root cause analysis, or post-market quality.
• Strong analytical, statistical, and problem-solving skills.
• Ability to lead investigations and collaborate effectively with cross-functional teams.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Knowledge of ISO 13485, FDA Quality System requirements, and applicable MDR requirements.
• Experience with Interventional Cardiology devices.
• Hands-on experience with X-Ray, FTIR, or SEM.
• Experience mentoring investigators and supporting quality improvement initiatives.

Key Skills:
Complaint Handling, Post-Market Surveillance, Medical Devices, CAPA, NCEP, Root Cause Analysis, Technical Investigations, ISO 13485, FDA Quality Systems, MDR, X-Ray, FTIR, SEM, Statistical Analysis, Continuous Improvement.

Contact to Apply:
Name: Soundarya Kondra
Email:
INTELLECTT INC

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

Equal Employment Opportunity:
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.