Senior Product Quality Engineer
HologicMarlborough, Massachusetts, United States
Posted October 31, 2025
97600 - 152700 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 to ensure the quality and safety of medical devices. This role involves leading investigations into post-market feedback, conducting root cause analyses, and implementing corrective/preventive actions to meet industry standards. The ideal candidate will be proactive and problem-solver with experience in quality, risk management, and engineering.
Requirements
- Strong understanding of FDA Quality System Regulations
- In-depth knowledge of ISO 13485, EU Medical Device Regulation, and ISO 14971
- Familiarity with test method validation, root cause failure analysis, and statistical methods
- Knowledge of system-level requirements for complex medical devices (software, electromechanical, hardware)
- Awareness of reliability, electrical safety, sterilization, packaging, and biocompatibility standards
Benefits
- Comprehensive training
- Ongoing development
- Continuous career growth