Sr Quality Systems Specialist

Hologic is seeking a Senior Quality Systems Specialist to strengthen and sustain our Quality Management System (QMS) and quality operations.

Requirements

• Working understanding of Quality Management Systems (QMS), especially Management Review, Quality System audits, CAPA, nonconformances, and quality planning.
• Knowledge and experience with ISO 13485, MDSAP, EU MDR, and 21 CFR 820/QMSR in a medical device or IVD environment.
• Familiarity with internal and external audit expectations and documentation needs (front-room/back-room).
• Understanding of GMP concepts and quality system processes such as Quality Agreements, Quality Plans (QPLs), and Periodic Review.

Benefits

• Comprehensive training
• Continued development and training throughout your career