Post-Market Quality Engineer — Complaints & CAPA Lead

United Pharma Technologies Inc; Minnesota; On-site; USD 90,000 - 130,000; Full time

Job summary

United Pharma Technologies Inc. seeks a Complaints Engineer to lead post-market quality activities for interventional cardiology medical devices.

This role will spearhead investigations and root-cause analysis, escalating product concerns and driving effective corrective actions. The engineer will collaborate with Quality, R&D, Design, Manufacturing, and Post-Market teams to identify issues, mentor investigators, and ensure compliance with ISO 13485, FDA QSR, and MDR requirements.

Qualifications

• Bachelor’s degree in engineering, science, or related technical field required.
• Experience in medical device quality engineering, complaints, CAPA, or post-market surveillance preferred.
• Strong root cause analysis and problem-solving skills essential.
• Ability to lead investigations and influence cross-functional teams.

Responsibilities

• Analyze complaints and post-market data to identify trends and issues.
• Lead technical investigations and root-cause analyses for escalated complaints.
• Document investigation findings and supporting evidence in the quality system.
• Own or support CAPAs and NCEPs resulting from investigations.

Skills

Root cause analysis

Technical investigations

Problem solving

Analytical statistics

Cross-functional leadership

Education

Bachelor's degree in Engineering, Science, or a related technical field

Tools

X-Ray

FTIR

SEM

Job description

United Pharma Technologies Inc. seeks a Complaints Engineer to lead post-market quality activities for interventional cardiology medical devices.

This role will spearhead investigations and root-cause analysis, escalating product concerns and driving effective corrective actions. The engineer will collaborate with Quality, R&D, Design, Manufacturing, and Post-Market teams to identify issues, mentor investigators, and ensure compliance with ISO 13485, FDA QSR, and MDR requirements.