Hologic, Inc. · 2 months ago
Sr Manager, Quality Assurance
Newark, DE, United States
Full-time
Onsite
Senior Level, Lead/Staff
$135K/yr - $224K/yr
8+ years expHologic, Inc. is seeking a Senior Manager, Quality Assurance to lead the development and maintenance of their Quality Management System. This role involves overseeing quality processes and ensuring compliance with global regulatory standards while mentoring a high-performing team.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead the development, implementation, and maintenance of the divisional Quality Management System (QMS)
Oversee key quality processes, including CAPA management, audits, change management, and Quality Management Reviews
Foster a culture of procedural compliance and continuous improvement
Partner cross-functionally and mentor a high-performing team
Ensure adherence to global regulatory standards
Qualification
Required
Bachelor's degree required
8+ years of experience with a Bachelor's degree or 5+ years with a Master's degree in Quality Assurance or a related field
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
Proven ability to recruit, lead, and develop a high-performing team with strong mentoring and coaching capabilities
Exceptional leadership skills with the ability to influence and communicate effectively across all levels of the organization
Strong project management skills to lead quality initiatives, manage resources, and meet financial objectives
Analytical skills to collect, compile, and interpret quality data to drive decision-making and improvements
Ability to support audits and regulatory inspections as a Subject Matter Expert (SME) and ensure readiness
Strong collaboration skills to establish cross-functional networks and drive procedural compliance
Strategic thinker, with a focus on aligning quality objectives to organizational goals and regulatory requirements
Detail-oriented and proactive, ensuring timely resolution of compliance issues and adherence to QMS processes
Collaborative and relationship-oriented, fostering strong partnerships across operations, R&D, and other functions
Promotes a culture of continuous improvement, identifying lessons learned and implementing new tools and methodologies
Accountable and results-driven, with a commitment to delivering high-quality outcomes while meeting financial objectives
Customer-focused, ensuring products meet the highest standards of safety, quality, and reliability
Preferred
Master's degree or PhD preferred
Prior experience in FDA, Notified Body, ISO, or other regulated manufacturing settings is beneficial
Proven success in leading quality initiatives, CAPA processes, audits, and change management in a regulated industry
Experience working with Operations and R&D teams to drive quality and compliance is advantageous
Previous managerial or supervisory experience is preferred
Lean or Six Sigma certification for driving process efficiency and continuous improvement
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
Company data provided by crunchbase