- Location: California, United States
- Type: Contract
- Job ID: 10545
- Work Setting: On-Site
- Posted: August 19, 2026
- Closing Date: August 31, 2027
- Tax Status: W2
Quality Engineering Analyst
12-Month Contract
Onsite in Alameda, CA
Must be able to work on a W2
Position Summary
Our client is seeking a Quality Engineering Analyst to support complaint management, quality investigations, data analysis, and trending activities within a regulated medical device environment. This individual will evaluate medical and non-medical complaints, stability investigation requests, and quality data to identify trends, potential risks, and root causes. The analyst will use technical judgment to determine the appropriate level of investigation based on risk and non-conformance, maintain complaint tracking and reporting systems, and collaborate with cross-functional teams to support quality system compliance and continuous improvement.
Responsibilities
12-Month Contract
Onsite in Alameda, CA
Must be able to work on a W2
Position Summary
Our client is seeking a Quality Engineering Analyst to support complaint management, quality investigations, data analysis, and trending activities within a regulated medical device environment. This individual will evaluate medical and non-medical complaints, stability investigation requests, and quality data to identify trends, potential risks, and root causes. The analyst will use technical judgment to determine the appropriate level of investigation based on risk and non-conformance, maintain complaint tracking and reporting systems, and collaborate with cross-functional teams to support quality system compliance and continuous improvement.
Responsibilities
- Design, maintain, and manage complaint tracking and reporting systems.
- Evaluate medical and non-medical complaints and stability investigation requests.
- Analyze complaint, quality, stability, and process data to identify trends, recurring issues, and potential risks.
- Use technical judgment and risk assessment to determine the appropriate depth of investigation.
- Review shipping, manufacturing, equipment, validation, engineering, testing/inspection, and product specification data.
- Review employee training records, Basic Operating Procedures, SPC/quality trend data, and stability reports as applicable.
- Support root cause investigations and identify potential contributing factors.
- Maintain tracking and follow-up systems to ensure Quality Engineering activities are completed accurately and on time.
- Support compliance with FDA Quality Systems Inspection Techniques (QSIT) and applicable quality system requirements.
- Prepare reports, dashboards, and data visualizations to communicate quality trends and investigation findings.
- Partner with Quality, Manufacturing, Operations, Engineering, and R&D teams to investigate product and process concerns.
- Identify opportunities for continuous improvement based on complaint and quality data.
- Bachelor’s degree in Biomedical Engineering, Engineering, Science, or a related technical discipline.
- 2–3 years of experience in the medical device, pharmaceutical, FDA-regulated, ISO-regulated, or other highly regulated industry.
- Experience with quality data analysis and trending investigations.
- Experience with complaint handling and complaint trend analysis.
- Experience or exposure to CAPA and root cause investigations.
- Strong understanding of quality systems and FDA/ISO requirements.
- Strong analytical, problem-solving, and technical judgment skills.
- Proficiency with Microsoft Excel and quality tracking/reporting systems.
- Experience with JMP, SQL, Power BI, Python, quality databases, dashboard development, or data visualization is preferred.
- ASQ Certified Quality Engineer (CQE) or equivalent certification is preferred.
- Strong communication skills and ability to work effectively with cross-functional teams.