Quality Engineer – Complaints

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

Job Function: Quality Engineering – Complaints / CAPA / Post-Market

Industry: Medical Devices – Interventional Cardiology

Position Summary

We are seeking a Complaints Engineer to support post-market quality activities for Interventional Cardiology (IC) medical devices. This role will lead technical investigations, root cause analysis, and escalation of product complaints and post-market signals. The engineer will work cross-functionally with Quality, R&D, Design, Manufacturing, and Post-Market teams to identify product issues and drive effective corrective actions.

Key Responsibilities

• Analyze complaints, adverse events, and post-market surveillance data to identify product trends and potential safety or quality issues.
• Lead technical investigations and root cause analysis for escalated product complaints and signals.
• Document investigation findings, conclusions, and supporting evidence within the quality system.
• Own or support CAPAs and NCEPs resulting from complaint investigations and product performance trends.
• Partner with R&D, Design Engineering, Quality, Manufacturing, and other cross-functional teams to resolve product issues.
• Present investigation findings, product performance trends, and recommendations to leadership and design teams.
• Support product performance reporting and technical documentation for post-market activities.
• Mentor and provide technical guidance to product complaint investigators.
• Drive effective use of investigative and analytical equipment, including X-Ray, FTIR, and SEM.
• Identify opportunities for continuous improvement across local and global Post-Market Quality teams.
• Ensure investigations and corrective actions are completed in accordance with applicable quality and regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field.
• Experience in medical device Quality Engineering, Complaints, CAPA, Post-Market Surveillance, or failure investigation.
• Strong experience with root cause analysis, technical investigations, and problem-solving.
• Strong analytical and statistical skills with the ability to interpret product and complaint data.
• Ability to lead investigations and influence cross-functional teams.

Preferred Qualifications

• Knowledge of ISO 13485, FDA QSR, and Medical Device Reporting (MDR) requirements.
• Experience with CAPA, NCEP, complaint handling, and post-market surveillance.
• Experience investigating Interventional Cardiology or other complex medical devices.
• Familiarity with analytical/investigative tools such as X-Ray, FTIR, and SEM.
• Experience presenting technical findings to leadership and R&D/Design teams.