Hologic is seeking a Quality Engineer to support validation efforts, risk management, and compliance within their Quality Management System to improve lives worldwide
Requirements
- Foundational understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualifications
- 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
- Basic proficiency in electronic document management systems
- Strong technical writing skills to support regulatory submissions and controlled documents
Responsibilities
- assist with process validations
- equipment qualifications
- risk assessments
- contribute to cross-functional teams for new product introductions and sustaining projects
- author and execute validation protocols, master validation plans, and reports under supervision
- assist in maintaining validation records and evaluating process specifications
- support quality investigations and process improvements
Other
- 0–2 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company
- Exposure to validation activities, including process validation and equipment qualification, is a plus
- Familiarity with Quality Management Systems and regulated environments preferred but not required
- Detail-oriented and committed to maintaining accuracy and compliance in all tasks
- Proactive and eager to learn, with a willingness to take on new challenges in a regulated environment
