Hologic is seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products, driving validation efforts, risk management, and supporting regulatory submissions.
Requirements
- Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification.
- Knowledge of risk analysis tools such as PFMEA and process risk assessments.
- Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
- Familiarity with change control processes and documentation requirements.
- Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans.
- Experience with electronic document management systems.
- Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications.
Responsibilities
- Lead validation efforts for analytical methods, equipment, processes, and facilities
- Drive risk management
- Support regulatory submissions
- Contribute to new product introductions
- Champion process improvements
- Authoring validation protocols, reports, master validation plans, and regulatory submission content
- Perform validation impact assessments and determine risk-based validation strategies
Other
- 2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
- Experience with regulatory submissions and understanding of quality systems in regulated industries.
- Strong interpersonal and collaboration skills to work effectively across departments and with cross-functional teams.
- Project management skills, including the ability to determine deliverables, set timelines, and manage departmental or cross-department projects.
- Detail-oriented and organized with a focus on accuracy and compliance.
