Senior Quality Investigator - Medical Devices & CAPA

Katalyst CRO; San Francisco (CA); Vor Ort; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Katalyst CRO in San Francisco 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 quality data, conduct root cause investigations, and ensure compliance with FDA and GMP standards.

The role involves reviewing complaints, performing RCA, supporting CAPA, and driving process improvements across cross-functional teams to enhance product quality and

Qualifikationen

• Bachelor's degree in Engineering required.
• Minimum 13 years of experience in the medical device industry.
• Knowledge of FDA QSR (21 CFR 820) and cGMP.
• Experience with complaint handling, investigations and RCA.
• Familiarity with CAPA processes and quality systems.
• Strong analytical and problem-solving skills.
• Experience with Minitab is a plus.
• Ability to read engineering drawings.
• Proficient in MS Office and databases.

Aufgaben

• Review customer complaints and 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 inputs to identify trends and systemic issues.
• Prepare investigation summaries, reports and recommendations.
• Review existing investigation reports and identify GMP compliance gaps.
• Support development and implementation of 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.

Kenntnisse

Root cause analysis

Analytical thinking

Data analysis

Quality systems

Problem solving

Statistical analysis

CAPA processes

Ausbildung

Bachelor's degree in Engineering

Tools

Minitab

MS Excel

MS Word

PowerPoint

Jobbeschreibung

Katalyst CRO in San Francisco 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 quality data, conduct root cause investigations, and ensure compliance with FDA and GMP standards.

The role involves reviewing complaints, performing RCA, supporting CAPA, and driving process improvements across cross-functional teams to enhance product quality and