Senior Quality Investigator, Medical Devices & CAPA

Katalyst CRO; Harrisburg (Dauphin County); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, quality system activities, and continuous improvement within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA, and ensuring compliance with FDA and GMP standards.

The candidate will review customer complaints, perform robust root cause analyses, and collaborate across functions to

Qualifications

• Bachelor's Degree in Engineering is 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 and databases.
• Ability to manage multiple tasks and projects effectively.

Responsibilities

• Review customer complaints and associated 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

Analytical thinking

Problem solving

Multi-tasking

Education

Bachelor's Degree in Engineering

Tools

Minitab

MS Office (Excel/Word/PowerPoint)

Databases

Job description

Katalyst CRO is seeking a Quality Complaint Investigation professional to support complaint investigations, quality system activities, and continuous improvement within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA, and ensuring compliance with FDA and GMP standards.

The candidate will review customer complaints, perform robust root cause analyses, and collaborate across functions to