Sr Manager, Quality Assurance

Senior Manager, Quality Assurance

Are you a strategic leader with a passion for driving compliance, quality excellence, and continuous improvement in a regulated environment? At Hologic, we are seeking a Senior Manager, Quality Assurance to lead the development, implementation, and maintenance of our divisional Quality Management System (QMS). In this role, you'll oversee key quality processes, including CAPA management, audits, change management, and Quality Management Reviews, while fostering a culture of procedural compliance and continuous improvement. You'll partner cross-functionally, mentor a high-performing team, and ensure adherence to global regulatory standards. If you're ready to make a meaningful impact by ensuring the safety, reliability, and quality of life-saving products, we encourage you to apply!

Knowledge

• Advanced understanding of Quality Management Systems (QMS) and electronic documentation systems.
• Expertise in FDA 21 CFR Part 820, ISO 13485 : 2016, EU MDR 2017 / 745, and other global regulatory standards.
• Expertise in managing CAPA processes, risk-based compliance strategies, and change management controls.
• Familiarity with root cause methodologies, risk management, and compliance-driven processes.
• Knowledge of Lean Manufacturing principles, Kaizen, Kanban, Poke Yoke, and visual factory ideology.
• Awareness of quality assurance standards, including statistical data analysis for quality performance.

Skills

Behaviors

Experience

Why Join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $134,700-$224,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.