Quality Complaint Investigator - Med Device & CAPA

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

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.