Hologic, Inc.
Systems Quality Engineer - Technical Investigation
Hologic, Inc., San Diego, California, United States, 92189
Overview
Systems Quality Engineer - Technical Investigation Position focused on coordinating complaint investigations within the Quality Technical Investigation (QTI) team for molecular diagnostic products. The role is hands-on and lab-based, involving testing, troubleshooting, and analyzing data related to hardware, software, and biochemical reagents. Apply critical thinking, statistical methods, and quality assurance practices to identify root causes and contribute to product improvements. Collaborate across functions to maintain compliance and drive results. 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. Apply critical thinking, statistical methods, and quality assurance practices to identify root causes and contribute to product improvements. Collaborate across functions to maintain compliance and drive results. 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. Salary and Benefits
The annualized base salary range for this role is $69,000-$101,000 and is bonus eligible. Final compensation packages depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Base pay range: $69,000.00/yr - $101,000.00/yr We are committed to making Hologic the destination for top talent. We provide comprehensive training and ongoing development and training throughout your career. Agency and Third-Party Recruiter Notice: Agencies submitting resumes to Hologic must have a current executed Hologic Agency Agreement and may only submit candidates invited 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. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Systems Quality Engineer - Technical Investigation Position focused on coordinating complaint investigations within the Quality Technical Investigation (QTI) team for molecular diagnostic products. The role is hands-on and lab-based, involving testing, troubleshooting, and analyzing data related to hardware, software, and biochemical reagents. Apply critical thinking, statistical methods, and quality assurance practices to identify root causes and contribute to product improvements. Collaborate across functions to maintain compliance and drive results. 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. Apply critical thinking, statistical methods, and quality assurance practices to identify root causes and contribute to product improvements. Collaborate across functions to maintain compliance and drive results. 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. Salary and Benefits
The annualized base salary range for this role is $69,000-$101,000 and is bonus eligible. Final compensation packages depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Base pay range: $69,000.00/yr - $101,000.00/yr We are committed to making Hologic the destination for top talent. We provide comprehensive training and ongoing development and training throughout your career. Agency and Third-Party Recruiter Notice: Agencies submitting resumes to Hologic must have a current executed Hologic Agency Agreement and may only submit candidates invited 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. Seniority level
Entry level Employment type
Full-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr