Quality Engineer

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

Job Summary:
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 aalytical, statistical, problem-solving, and cross-functional communication skills.

Contact to Apply:
Name: Pavani Samboju
Email:
Phone: 732 993 4972
INTELLECTT INC