Quality Assurance Engineer

Intellectt Inc; Arden Hills (MN); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Intellectt Inc in Arden Hills, MN seeks a Complaints Engineer with experience in medical device quality, post-market surveillance, and CAPA. You will investigate product complaints and adverse events, perform root cause analysis, and manage CAPA/NCEP activities.

You will analyze product performance data and collaborate with cross-functional teams to ensure regulatory compliance and continued device safety.

Qualifications

• Bachelor’s degree in Engineering or a related technical/scientific field.
• Experience in complaints, CAPA, root cause analysis, or post-market quality.
• Knowledge of ISO 13485, FDA QSR, and MDR preferred.
• Strong analytical, problem-solving, and communication skills.

Responsabilités

• Investigating product complaints and adverse events.
• Perform root cause analysis and manage CAPA/NCEP activities.
• Analyze product performance data and collaborate with cross-functional teams.

Connaissances

Analytical skills

Communication skills

Formation

Bachelor's degree in Engineering or related field

Description du poste

Seeking a Complaints Engineer with experience in medical device quality, post-market surveillance, and CAPA. Responsibilities include investigating product complaints and adverse events, performing root cause analysis, managing CAPA/NCEP activities, analyzing product performance data, and collaborating with cross-functional teams.

Requirements:

• Bachelor’s degree in Engineering or a related technical/scientific field.
• Experience in complaints, CAPA, root cause analysis, or post-market quality.
• Knowledge of ISO 13485, FDA QSR, and MDR preferred.
• Strong analytical, problem-solving, and communication skills.