Quality Engineering Analyst
LancesoftAlameda, CA
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Overview
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Job Description
Title: Quality Engineering Analyst (Tracking & Trending)Location: Alameda, CA 94502Duration: 12 MonthsPosition Overview:
- 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.
- 2 to 3 years of experience in a:
- Medical device industry (preferred)
- Pharmaceutical industry
- FDA and/or ISO regulated environment
- Bachelor's Degree in: Biomedical Engineering, or Related Engineering Discipline
- ASQ Certified Quality Engineer (CQE) or equivalent certification preferred
- 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
- 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
- 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.
- 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.
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FAQs About Quality Engineering Analyst Jobs at Lancesoft
What is the work location for this position at Lancesoft?
This job at Lancesoft is located in Alameda, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Lancesoft?
Candidates can expect a pay range of $45.
What employment applies to this position at Lancesoft?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Lancesoft?
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