Quality Analytics Engineer - Tracking & Trending

Select Source International; Alameda (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Select Source International is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis within a regulated medical device environment. You will perform trending investigations, analyze complaint data, identify product/process issues, and drive continuous improvement while ensuring FDA/ISO compliance.

The role collaborates with Quality, Operations, Manufacturing, and R&D teams to investigate concerns and present data-driven insights to

Qualifications

• 2–3 years of experience in a medical device, pharmaceutical, or FDA/ISO regulated environment.
• Bachelor's Degree in Biomedical Engineering or related engineering discipline.
• ASQ CQE or equivalent certification preferred.

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 using 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 and data-driven insights to stakeholders.

Skills

Quality data analysis

Trend analysis

CAPA support

Root cause investigation

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering or related engineering discipline

Tools

JMP

Power BI

SQL

Python

Excel

Job description

Select Source International is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis within a regulated medical device environment. You will perform trending investigations, analyze complaint data, identify product/process issues, and drive continuous improvement while ensuring FDA/ISO compliance.

The role collaborates with Quality, Operations, Manufacturing, and R&D teams to investigate concerns and present data-driven insights to