Quality Engineering Analyst

The Fountain Group is currently seeking a ­­­­­­­­Quality Engineering Analyst for a prominent client of ours. This position is located in ­­Alameda, CA. Details for the position are as follows:

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. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.
• 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

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

#LI-HH1