Senior Quality Investigator - Medical Devices & CAPA

Katalyst CRO; Lafayette (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device setting.

In this role you will analyze quality data, perform root-cause investigations, review GMP compliance, and collaborate cross-functionally to enhance product quality and regulatory adherence. A BE/B.Tech degree and extensive experience in the medical device industry are required.

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.

Responsibilities

• Review customer complaints and service data to determine risk levels and identify problem/cause codes.
• Conduct complaint investigations and perform detailed root cause analysis.
• Analyze data from quality systems including Complaints, FCA, FDA MDRs, and other quality inputs to identify trends and systemic issues.
• Prepare investigation summaries, reports, and recommendations based on analysis.
• Review existing investigation reports and identify GMP compliance gaps.
• Support development and implementation of corrective and preventive actions (CAPA).
• Drive continuous improvement initiatives and process control activities.
• Conduct data analysis using statistical and quality tools.
• Support maintenance activities for existing product lines and quality systems.
• Collaborate cross-functionally to improve product quality and compliance standards.

Skills

Quality data analysis

Root cause analysis

CAPA processes

Statistical tools

MS Office

Education

Bachelor's Degree in Engineering

Tools

Minitab

Job description

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, CAPA activities, and continuous improvement in a regulated medical device setting.

In this role you will analyze quality data, perform root-cause investigations, review GMP compliance, and collaborate cross-functionally to enhance product quality and regulatory adherence. A BE/B.Tech degree and extensive experience in the medical device industry are required.