Post-Market Quality Investigator & CAPA Lead

Stark Pharma Solutions Inc; Arden Hills (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Stark Pharma Solutions Inc in Arden Hills, MN is seeking a Complaints Engineer to own post-market data analysis and drive timely investigations.

You will lead root cause investigations, own CAPAs and NCEPs, and mentor investigators while presenting findings to leadership and design teams.

The role emphasizes cross-functional influence, utilization of statistical methods, and adherence to ISO 13485 and MDR requirements.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Cross-functional influence

Analytical problem-solving

Education

Bachelor's degree in engineering or related field

Job description

Stark Pharma Solutions Inc in Arden Hills, MN is seeking a Complaints Engineer to own post-market data analysis and drive timely investigations.

You will lead root cause investigations, own CAPAs and NCEPs, and mentor investigators while presenting findings to leadership and design teams.

The role emphasizes cross-functional influence, utilization of statistical methods, and adherence to ISO 13485 and MDR requirements.