Sr Manager, Quality Assurance

Hologic•Newark, NJ

11d

About The Position

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!

Requirements

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.
Bachelor’s degree required; Master’s degree or PhD preferred.
8+ years of experience with a Bachelor’s degree or 5+ years with a Master’s degree in Quality Assurance or a related field.
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

Nice To Haves

Lean or Six Sigma certification for driving process efficiency and continuous improvement.

Responsibilities

Lead the development, implementation, and maintenance of our 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
Mentor a high-performing team
Ensure adherence to global regulatory standards.