Quality Engineer

Summary

Katalyst CRO is a company focused on complaint investigations and quality system activities in the medical device manufacturing sector. The role involves analyzing quality data, conducting root cause investigations, and ensuring compliance with FDA and GMP standards.

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, Field Corrective Actions (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

• Bachelor's Degree in Engineering (B.E./B.Tech or equivalent)
• 1–3 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
• Experience with ANSI/ISO/ASQC standards
• Exposure to continuous improvement methodologies and process controls
• Knowledge of medical device regulatory environments and compliance practices

Qualifications

Must Haves

• Bachelor's Degree in Engineering (B.E./B.Tech or equivalent)
• 1–3 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

Nice to Haves

• Experience with ANSI/ISO/ASQC standards
• Exposure to continuous improvement methodologies and process controls
• Knowledge of medical device regulatory environments and compliance practices