Post-Market Complaints & Quality Engineer - RCA/CAPA Lead

Intellectt Inc

Arden Hills (MN)

On-site

USD 85,000 - 105,000

Full time

4 days ago

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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.