Systems Quality Engineer - Technical Investigation at 613.5310.0200 GYNESONICS - CORPORATE SALES MID-ATLANTIC REGION, US

Are you passionate about ensuring the quality and performance of life-saving molecular diagnostic products? At Hologic, we are seeking a Systems Quality Engineer  to coordinate complaint investigations within our Quality Technical Investigation (QTI) team. In this hands-on, lab-based role, you’ll test, troubleshoot, and analyze data related to hardware, software, and biochemical reagents used in molecular diagnostics. By applying critical thinking, statistical methods, and quality assurance practices, you’ll identify root causes and contribute to product improvements. If you’re detail-oriented, analytical, and eager to collaborate across functions to maintain compliance and drive results, we’d love for you to join our team!

Knowledge:

• 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.

Skills:

• Strong research and analytical skills to gather and interpret information from multiple sources.
• Technical aptitude for conducting system-level laboratory testing and inspections.
• 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.
• 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.

Behaviors:

• 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.

Experience:

• 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.
• Experience working with large datasets and using software tools like R, Python, or JMP is a plus.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $69,000-$101,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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