Quality Engineering Analyst

Quality Engineering Analyst

Location: Alameda, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 11 months
• Pay Rate: $59.98 / 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

• 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
• Advanced Excel skills: VBA, Macros, Power Query, Pivot Tables
• Strong understanding of Good Documentation Practices (GDP)
• Experience with SQL or Python for data analytics
• Background in medical devices or pharmaceuticals
• Ideal functional backgrounds: Quality, CAPA, or Complaint Handling

Preferred Skills

• JMP (used daily for statistical analysis)
• 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
• Exposure to complaint handling with involvement in root cause analysis

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
• Experience analyzing complaint and quality data
• Exposure to CAPA processes and root cause investigations
• Strong analytical and problem-solving capabilities
• 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

• Interview process is two steps: an initial video interview with the Hiring Manager and/or Team Lead, followed by a panel interview with key stakeholders. A case study may be included in the panel interview to demonstrate how the candidate would handle a particular scenario.

About the Client

This global healthcare innovator has spent more than 140 years at the forefront of medical advancement, developing life-changing technologies, diagnostics, nutritional science, and pharmaceutical products that reach patients in more than 160 countries. The organization's portfolio spans cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation, with recognized brands that millions of people rely on every day. The company operates across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals and employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals across its global network. Certified as a Great Place to Work, with 80 percent of employees affirming that distinction, this organization offers professionals the opportunity to contribute to healthcare breakthroughs that touch millions of lives within a culture grounded in inclusion, innovation, and long-term career growth.

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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