Quality Engineering Analyst

Quality Engineering Analyst

Location: Alameda, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 11 months
• Pay Rate: $58.53 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

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

• 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.
• Use judgment based on experience to determine the depth of the investigation required associated with the level of risk of non-conformance.
• 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.
• Present findings, recommendations, and data-driven insights to stakeholders.

Required 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 Skills

• 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

Education Requirements

• Bachelor's Degree in Biomedical Engineering or a related Engineering Discipline (required)
• ASQ Certified Quality Engineer (CQE) or equivalent certification (preferred)

Required Experience

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

Nice-to-Have Experience

• 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

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

Important Notes

• Two-Step Interview Process: Initial Video Interview with Hiring Manager and/or Team Lead, followed by a Panel Interview with Key Stakeholders.

About the Client

This global healthcare innovator has been at the forefront of medical advancement for more than 140 years, with a diverse portfolio spanning medical devices, diagnostics, nutritional science, and pharmaceutical products that reach patients in more than 160 countries. Operating across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals the organization develops groundbreaking technologies including continuous glucose monitoring systems, rapid diagnostic tests, minimally invasive cardiac devices, and nutritional solutions for patients across all life stages. With a workforce that includes biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals, the company has earned Great Place to Work certification, with 80 percent of employees reporting it as a great place to work well above the national average and offers cross-functional teams, international exposure, and a clear mission to improve global health outcomes.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-11836 Industry: Data & Analytics

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