Quality Engineer 2
HologicMarlborough, Massachusetts, United States
Posted October 30, 2025
78000 - 122100 USD year
Full Time
About the Company
Hologic is an innovative medical technology company dedicated to enabling healthier lives through groundbreaking products and services. Specializing in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions, the company excels in early detection and treatment of health conditions, driven by a commitment to women's health and a focus on clinical superiority. Hologic fosters a culture of expertise, dedication, and continuous improvement to meet unmet health needs globally.
Job Description
Hologic is seeking a Quality Engineer II – Quality Technical Investigations (QTI) to lead root cause analysis and resolve product complaints for electromechanical in vitro diagnostic (IVD) devices. The role involves collaborating with design, manufacturing, and service teams to enhance product reliability and ensure customer satisfaction. They are passionate about quality and problem-solving.
Requirements
- Expertise in complaint investigations, root cause analysis, and sustaining engineering for medical devices.
- Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR.
- Familiarity with reliability and systems engineering principles.
- Awareness of post-market surveillance and continuous improvement methodologies, such as 5S.
- Bachelor’s degree in engineering or a related technical field.
- 2–4 years of experience in quality, reliability, or systems engineering within the medical device or related regulated industry.
Benefits
- Comprehensive training
- Continued development and training