Quality Engineer
HologicSan Diego, California, United States
Posted October 1, 2025
69000 - 101100 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 support validation efforts, risk management, and compliance within their Quality Management System. The role involves assisting with process validations, equipment qualification, and risk assessments, and contributing to cross-functional projects within new product introductions and sustaining projects. The company prioritizes improving lives through innovative healthcare products.
Requirements
- Foundational understanding of validation methods
- Basic knowledge of risk analysis techniques, such as PFMEA and process risk assessments
- Familiarity with regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11
- Awareness of change control processes and documentation requirements
- Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling methods
- Strong analytical and problem-solving skills
Benefits
- Comprehensive training
- Continued development
- Training throughout career