Sr Quality Engineer - Post Market Data Analyst
New
I
Integrated DNA TechnologiesLife Sciences
Fully remote within the United StatesFull-TimeSenior
SalaryUSD 66000 - 115500 / year
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Job Details
- Experience
- Bachelor's degree with 5+ years of relevant experience, OR a Master's degree with 3+ years of relevant experience
- Required Skills
- PythonSQLMicrosoft Power BITableauMicrosoft ExcelR
Requirements
- Bachelor's degree in Engineering, Data Science, Statistics, Computer Science, Quality, or related discipline with 5+ years of relevant experience.
- Alternative: Master's degree in a related field with 3+ years of relevant experience.
- Experience developing and maintaining business intelligence and reporting solutions using Power BI, Tableau, or similar platforms.
- Proficiency in statistical analysis and data management tools, including SQL and Microsoft Excel.
- Experience using Minitab, JMP, R, or Python.
- Working knowledge of ISO 13485, 21 CFR Part 820, and 21 CFR Part 803.
- Experience with CAPA, complaint handling, and risk management processes.
- Ability to travel up to 10% for meetings, training, and audits.
- Ability to work at a computer for extended periods.
Responsibilities
- Develop, maintain, and automate complaint analytics dashboards, reports, and statistical trend analyses.
- Ensure the integrity, accuracy, and governance of complaint and quality system data.
- Provide data-driven support for complaint investigations, root cause analysis, risk management, and CAPA effectiveness evaluations.
- Collaborate with Quality, Regulatory, Scientific Application Support, Product Development, and Manufacturing teams.
- Support regulatory compliance, internal and external audits, and inspections through reporting and documentation.
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