Quality Engineering Analyst

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

Job Title: Quality Engineering Analyst (Tracking & Trending)

Location: Alameda, CA 94502 - Onsite

Duration: 12 months contract with possible extension

Shift/Schedule: 8:00 AM 5:00 PM/ Monday Friday

Position Overview

Our client is seeking a 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

Experience Required

2 to 3 years of experience in a: Medical device industry (preferred), Pharmaceutical industry, FDA and/or ISO regulated environment

Required Education

Bachelor's Degree in Biomedical Engineering, or Related Engineering Discipline

Preferred Certifications

ASQ Certified Quality Engineer (CQE) or equivalent certification preferred

Required Technical Skills

Candidates should possess experience in the following areas:

• 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

Preferred Qualifications

• Strong preference for candidates with experience in: 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