Hologic, Inc. · 3 months ago
Systems Quality Engineer - Technical Investigation
San Diego, CA, United States
Full-time
Onsite
New Grad, Entry Level
$69K/yr - $101K/yr
0+ years expHologic, Inc. is a company dedicated to improving women's health through innovative solutions. They are seeking a Systems Quality Engineer to coordinate complaint investigations and ensure the quality and performance of molecular diagnostic products. This role involves testing, troubleshooting, and analyzing data related to hardware, software, and biochemical reagents while applying quality assurance practices and statistical methods.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Coordinate complaint investigations within the Quality Technical Investigation (QTI) team
Test, troubleshoot, and analyze data related to hardware, software, and biochemical reagents used in molecular diagnostics
Identify root causes and contribute to product improvements
Maintain compliance and drive results through collaboration across functions
Qualification
Required
Master's Level Degree
Understanding of molecular diagnostic assays, including their design, function, and usage
Basic knowledge of electromechanical, pneumatic, optical, and software systems troubleshooting
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
Strong research and analytical skills to gather and interpret information from multiple sources
Technical aptitude for conducting system-level laboratory testing and inspections
Ability to write scripts for automating data analysis and applying specialized data analysis tools
Effective communication skills to present complex technical information in oral and written formats
Organized and detail-oriented with the ability to manage multiple investigations and meet deadlines
Collaboration and teamwork skills to work effectively with cross-functional partners
Proactive problem solver who thrives in a hands-on, lab-based environment
Analytical and detail-oriented, with a focus on accuracy and compliance
Collaborative and adaptable, building strong partnerships across functions
Eager to learn and apply new tools, methods, and techniques to improve processes
Accountable and results-driven, ensuring timely completion of investigations and documentation
Dedicated to continuous improvement and maintaining high standards of quality
0–2 years of experience in research, development, or manufacturing roles, preferably in vitro diagnostics or medical devices
Preferred
Laboratory experience in research and/or clinical settings
Prior experience with molecular detection assays and statistical methods
Exposure to quality systems such as ISO 13485 and risk assessments under ISO 14971
Experience working with large datasets and using software tools like R, Python, or JMP
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase