Quality Engineer

Katalyst CRO; Elmore (OH); On-site; USD 95,000 - 125,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Analytical thinking

Root cause analysis

Data analysis

Problem solving

Education

Bachelor's Degree in Engineering

Tools

Minitab

Job description

Job Summary

We are seeking a Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, 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.

Requirements

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

Preferred Experience

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

Work Environment

• FDA-regulated manufacturing environment.
• Temperature and humidity-controlled workspace.
• May require use of static-protective equipment while in designated work areas.

Physical Requirements

• Ability to sit for extended periods.
• Good hand-eye coordination and dexterity.
• Ability to lift up to 40 lbs when required.