Lead Risk Management Quality Engineer
HologicMarlborough, Massachusetts, United States
Posted February 10, 2026
119300 - 186600 USD
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
Lead Risk Management Quality Engineer to ensure the safety and compliance of on-market and pre-market medical devices by serving as the organization's key risk expert.
Requirements
- Deep expertise in ISO 14971:2019 and EU MDR risk requirements
- Strong understanding of FDA Quality System Regulations and ISO 13485
- In-depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technologies
- Working knowledge of verification and validation requirements in the medical device industry
- Understanding of requirements analysis, including development of testable and measurable specifications
Benefits
- Comprehensive training when you join as well as continued development and training throughout your career
- Bonus eligible annualized base salary range $119,300-$186,600