Quality Engineering Analyst

The Fountain Group; Alameda (CA); On-site; USD 55,000 - 81,000; Full time

Job summary

The Fountain Group is seeking a Quality Engineering Analyst for a prominent client in Alameda, CA. This is a 1-year W2 contract, 100% onsite, with a pay range of $40-$59 per hour, depending on experience.

The role focuses on tracking and trending quality data, supporting root cause investigations, CAPA, and continuous improvement in a regulated medical device environment. You will design dashboards using Excel, Power BI, JMP, SQL, and Python, and collaborate with Quality, Operations,

Qualifications

• 2 to 3 years of quality experience in FDA/ISO regulated environment.
• Bachelor's Degree in Biomedical Engineering or related engineering discipline.
• 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.

Responsibilities

• Perform complaint tracking and trending activities.
• Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.
• Support root cause investigations and CAPA activities.
• Evaluate quality data to identify trends, risks, and issues.
• Collaborate with Quality, Operations, Manufacturing, and R&D teams.
• Document investigative findings and support regulatory compliance requirements.

Skills

Quality data analysis

Trending investigations

CAPA

Root cause investigation

Cross-functional collaboration

Data analysis & reporting

Education

Bachelor's degree in Biomedical Engineering or related engineering

Tools

Excel

Power BI

JMP

SQL

Python

Job description

The Fountain Group is currently seeking a Quality Engineering Analyst for a prominent client of ours. This position is located in Alameda, CA.

Pay Range: $40 - 59/hr depending on experience. W2 Contract: 1 year with possible extension and/or conversion. 100% onsite in Alameda, CA (non-local candidates must be able to relocate at own expense).

Job Description

• Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment.
• Responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives.
• Design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem.
• Evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem.
• Maintain a tracking and follow up system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques.
• 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.

Qualifications

• 2 to 3 years of quality experience in any of the following: Medical device industry (preferred), Pharmaceutical industry, or FDA and/or ISO regulated environment.
• Bachelor's Degree in: Biomedical Engineering, or Related Engineering Discipline.
• 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.