Sr Manager, Quality Assurance
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.
- 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
- 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
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Industry
Computer and Electronic Product Manufacturing
Number of Employees
5,001-10,000 employees
