Senior Quality Investigator - Medical Devices & CAPA

Katalyst CRO; Elmore (OH); Sur place; USD 95 000 - 125 000; Plein temps

Résumé du poste

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, quality system activities, and CAPA within a regulated medical device manufacturing environment. The role emphasizes data analysis, root cause investigations, and GMP adherence.

You will analyze quality data, conduct root cause investigations, and collaborate cross-functionally to improve product quality and FDA compliance across multiple teams.

Qualifications

• Bachelor's Degree in Engineering required.
• 13 years of experience in the Medical Device industry.
• Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
• Experience in complaint handling, investigations, and root cause analysis.
• Familiarity with CAPA processes and quality systems.
• Strong analytical and problem-solving skills.
• Experience with statistical tools/software such as Minitab is a plus.
• Ability to read and interpret technical drawings and engineering documentation.
• Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
• Ability to manage multiple tasks and projects effectively.

Responsabilités

• Review customer complaints and identify risk levels and problem codes.
• Conduct complaint investigations and perform root cause analysis.
• Analyze data from quality systems to identify trends and systemic issues.
• Prepare investigation summaries, reports, and recommendations.
• Review investigation reports and GMP compliance gaps.
• Support development and implementation of CAPAs.
• Drive continuous improvement and process control activities.
• Conduct data analysis using statistical tools.
• Support maintenance activities for existing product lines and quality systems.
• Collaborate cross-functionally to improve product quality and compliance standards.

Connaissances

Analytical thinking

Root cause analysis

Data analysis

Problem solving

Formation

Bachelor's Degree in Engineering

Outils

Minitab

Description du poste

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, quality system activities, and CAPA within a regulated medical device manufacturing environment. The role emphasizes data analysis, root cause investigations, and GMP adherence.

You will analyze quality data, conduct root cause investigations, and collaborate cross-functionally to improve product quality and FDA compliance across multiple teams.