Quality Engineer

Katalyst CRO; San Francisco (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a Quality Complaint Investigator to support complaint investigations, quality system activities, and continuous improvement in a regulated medical device environment. You will analyze data, perform root cause investigations, and support CAPA while ensuring FDA and GMP compliance.

The role requires expertise in quality analytics, CAPA processes, and cross-functional collaboration to enhance product quality and regulatory adherence.

Qualifications

• 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.

Responsibilities

• Review customer complaints and related data to assess risk and identify 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 for GMP compliance gaps.
• Support CAPA development and implementation.
• Drive continuous improvement and process controls.
• Conduct data analysis using statistical tools.
• Support maintenance of product lines and quality systems.
• Collaborate cross-functionally to improve quality and compliance.

Skills

Root cause analysis

Analytical skills

Problem solving

Regulatory knowledge

Cross-functional collaboration

Education

B.E./B.Tech in Engineering

Tools

Minitab

MS Excel

MS Word

PowerPoint

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.