Medical Device Complaints Analyst

The Fountain Group; Alameda (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Fountain Group is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis in a regulated medical device environment. You will conduct trending investigations and analyze complaint data to identify potential product and process issues while supporting root cause investigations and continuous improvement efforts.

Collaborating with Quality, Operations, Manufacturing, and R&D teams, you will ensure compliance with FDA/ISO quality system

Qualifications

• BS in Biomedical Engineering or equivalent in a regulated environment.
• Experience with complaint data analysis and trending investigations.
• Familiarity with CAPA processes and root cause investigations.
• Experience in FDA/ISO quality systems.
• Proficiency with Excel and data analytics tools.

Responsibilities

• Perform complaint tracking and trending in quality databases using analytical tools.

Skills

Quality data analysis

Complaint trend analysis

CAPA investigations

Excel

Power BI

SQL querying

Python basics

Data visualization

Cross-functional collaboration

JMP

Dashboard development

Education

BS in Biomedical Engineering

Tools

JMP

Power BI

SQL

Python

Excel

Job description

MUST BE LOCAL TO THE ALAMEDA CA LOCATION

REQUIRED:

• BS in Biomedical Engineering preferred
• Quality data analysis and trending investigations
• Complaint handling and complaint trend analysis
• CAPA support and root cause investigation methodologies
• Quality systems within FDA-regulated environments
• Data analysis and reporting using Excel and related analytics tools
• Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams
• JMP
• Advanced Microsoft Excel
• SQL querying and data analysis
• Power BI
• Basic to intermediate Python programming
• Quality and complaint management databases
• Dashboard development and data visualization

Preferred Certifications

• ASQ Certified Quality Engineer (CQE)

Job Description:

Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Key Responsibilities

Perform complaint tracking and trending activities using quality databases and analytical tools.

Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.

Support root cause investigations and CAPA activities.

Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.

Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.

Document investigative findings and support regulatory compliance requirements.

Assist with continuous improvement initiatives related to complaint handling and quality trending processes.

Present findings, recommendations, and data-driven insights to stakeholders.

Ideal Candidate Profile

The ideal candidate will have:

Experience working in a medical device or other highly regulated environment.

Strong analytical and problem-solving capabilities.

Experience analyzing complaint and quality data.

Exposure to CAPA processes and root cause investigations.

Ability to communicate technical findings clearly to cross-functional stakeholders.

Proficiency with data analytics and reporting tools.