Complaints Engineer

Shoolin Inc; Minnesota; In loco; USD 80.000 - 110.000; Tempo pieno

Descrizione del lavoro

Shoolin Inc. in Minnesota is seeking a Quality Investigator to analyze post-market surveillance data and drive timely investigations of safety and quality issues.

You will lead root cause investigations and document findings in the quality system, with potential ownership of CAPAs as needed. You will present product performance insights to leadership and design teams, support published performance reports, and mentor investigators in using tools like X-Ray, FTIR, and SEM.

Competenze

• Bachelor's degree in engineering or a related technical or scientific field is required.
• ISO 13485, QSR, and MDR knowledge preferred.
• Strong cross-functional influence and statistical or analytical problem-solving skills.

Mansioni

• Analyze post-market surveillance data (complaints, adverse events) to drive timely investigation and resolution of safety and quality issues
• Lead root cause investigations on escalated product signals and document findings in the quality system
• May own NCEPs and CAPAs directly
• Present product performance insights to leadership and design teams and support published performance reports
• Mentor product investigators and drive utilization of investigative equipment such as X-Ray, FTIR, and SEM
• Champion continuous improvement initiatives across local and global Post Market teams

Conoscenze

Post-market surveillance

Root cause analysis

Investigations

Cross-functional influence

Statistical analysis

Formazione

Bachelor's degree in engineering or related technical field

Strumenti

X-Ray

FTIR

SEM

Descrizione del lavoro

*Think of this as QE (Complaints/CAPA/Post Market)

What you'll own:

• Analyze post-market surveillance data (complaints, adverse events) to drive timely investigation and resolution of safety and quality issues
• Lead root cause investigations on escalated product signals and document findings in the quality system
• May own NCEPs and CAPAs directly
• Present product performance insights to leadership and design teams and support published performance reports
• Mentor product investigators and drive utilization of investigative equipment such as X-Ray, FTIR, and SEM
• Champion continuous improvement initiatives across local and global Post Market teams

Requirements:

• Bachelor's degree in engineering or a related technical or scientific field (required)
• ISO 13485, QSR, and MDR knowledge preferred
• Strong cross-functional influence and statistical or analytical problem-solving skills