Openings: 1
Position Overview
We are seeking a Quality Engineering Analyst with a strong background in quality engineering, quality investigations, data analysis, and trend analysis. The ideal candidate will bring solid hands-on quality expertise rather than a primarily data-analytics-focused background.
Experience within the medical device or pharmaceutical industry is highly preferred and considered critical. Candidates with extensive experience, including 10+ years, are welcome to apply. Relocation candidates may be considered if willing to relocate at their own expense.

Key Responsibilities
Analyze aggregate complaint and quality datasets rather than processing individual complaints.
Perform data tracking, trending, and statistical analysis to identify emerging quality trends.
Identify significant patterns within datasets and initiate appropriate quality investigations.
Conduct approximately 20 trend investigations per month.
Perform root cause and CAPA-related investigations using structured quality methodologies.
Analyze complex datasets and translate findings into meaningful quality conclusions.
Clearly document investigation results, conclusions, and supporting evidence in accordance with Good Documentation Practices (GDP).
Utilize tools such as JMP, Advanced Excel, SQL, and Python to support quality data analysis.
Apply strong analytical and critical-thinking skills to evaluate quality issues and recommend appropriate actions.

Required & Preferred Qualifications
Bachelor's degree in Biomedical Engineering or a related Engineering discipline preferred/required.
A bachelor's degree in Science alone is generally not sufficient unless supported by relevant engineering experience.
Minimum 2 years of quality engineering experience.
Experience with quality investigations, data analysis, tracking, and trending.
Strong background in medical device or pharmaceutical environments highly preferred.

Technical Skills
Quality Engineering & Quality Investigations | Data Tracking & Trending |Advanced Excel – Pivot Tables, Macros, Power Query, Power BI | JMP | SQL | Python | CAPA Investigations | Root Cause Analysis | Good Documentation Practices (GDP)

Quality Engineering Analyst

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