Quality Engineering Analyst

Job Posting Title: Quality Engineering Analyst (Tracking & Trending)

Duration: 12 Months

Location: Alameda, CA 94502

Position Overview We are seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This position is NonExempt (overtime over 40 hours paid at time and a half). The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests; and apply technical judgment to determine problem nature and investigation depth based on risk level.

Key Responsibilities

Design, maintain, and manage the complaint tracking and reporting system to ensure compliance with FDA Quality Systems Inspection Techniques and ISO requirements.

Perform complaint tracking, trending activities, and stability investigation requests using quality databases and analytical tools.

Evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records, Basic Operating Procedures, SPC/quality trend data, and stability reports to determine root causes.

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 maintain a tracking and follow-up system to ensure ongoing compliance.

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

Required Education & Experience

Education: Bachelor's Degree in Sciences, Biomedical Engineering, or a Related Engineering Discipline.

Experience: 2 to 3 years of experience in a medical device industry (preferred), pharmaceutical industry, or other FDA and/or ISO-regulated environment.

Required Technical Skills

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

Certifications: ASQ Certified Quality Engineer (CQE) or equivalent.

Technical Proficiency: Experience with JMP, Advanced Microsoft Excel, SQL querying and data analysis, Power BI, and basic-to-intermediate Python programming.

Familiarity with quality and complaint management databases, dashboard development, and data visualization.

Ideal Candidate Profile

Strong analytical, technical judgment, and problem-solving capabilities.

Experience analyzing complaint and quality data with exposure to CAPA processes and root cause investigations.

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

Interview Process

Step 1: Initial Video Interview with Hiring Manager and/or Team Lead

Step 2: Panel Interview with Key Stakeholders