Hologic is seeking a Systems Quality Engineer to coordinate complaint investigations within their Quality Technical Investigation (QTI) team to ensure the quality and performance of life-saving molecular diagnostic products.
Requirements
- Proficiency in statistical analysis and data trending; experience with R, Python, and JMP preferred.
- Ability to write scripts for automating data analysis and applying specialized data analysis tools.
- Experience working with large datasets and using software tools like R, Python, or JMP is a plus.
- Familiarity with ISO 13485 quality management systems and ISO 14971 risk assessment principles.
- Knowledge of statistical methods and tools for analyzing large datasets.
- Awareness of root cause analysis and problem-solving methodologies.
- Basic knowledge of electromechanical, pneumatic, optical, and software systems troubleshooting.
Responsibilities
- Test, troubleshoot, and analyze data related to hardware, software, and biochemical reagents used in molecular diagnostics.
- Apply critical thinking, statistical methods, and quality assurance practices to identify root causes and contribute to product improvements.
- Conduct system-level laboratory testing and inspections.
- Write scripts for automating data analysis and applying specialized data analysis tools.
- Analyze large datasets.
- Perform root cause analysis.
- Troubleshoot electromechanical, pneumatic, optical, and software systems.
Other
- 0–2 years of experience in research, development, or manufacturing roles, preferably in vitro diagnostics or medical devices.
- Laboratory experience in research and/or clinical settings preferred.
- Prior experience with molecular detection assays and statistical methods is beneficial.
- Exposure to quality systems such as ISO 13485 and risk assessments under ISO 14971 preferred.
- Detail-oriented, analytical, and eager to collaborate across functions to maintain compliance and drive results.
