Hologic is seeking a Senior Manager, Post-Market Quality & Product Improvement to lead post-market investigations, manage quality-related business processes, and implement product changes informed by customer feedback and data to ensure products remain safe, compliant, and aligned with customer needs.
Requirements
- Comprehensive understanding of Post-Market quality processes, including complaint handling, root cause analysis, and regulatory reporting.
- In-depth knowledge of regulatory requirements such as 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR.
- Expertise in design verification/validation, GMP, and Quality Systems Regulations.
- Familiarity with risk management processes (e.g., ISO 14971), CAPA, and change control procedures.
- Proficiency in CAD tools (e.g., SolidWorks), statistical analysis software (e.g., MiniTab), and metrics development.
- Advanced analytical skills for trend analysis, root cause investigations, and data-driven decision-making.
- Ability to troubleshoot product, process, and component issues using sound engineering principles.
Responsibilities
- Lead post-market investigations
- Manage quality-related business processes
- Implement product changes informed by customer feedback and data
- Oversee a team of Quality Design Engineers (QDEs)
- Ensure our products remain safe, compliant, and aligned with customer needs
- Troubleshoot product, process, and component issues using sound engineering principles
- Translate post-market data into actionable product and process improvements
Other
- Strong leadership skills to hire, mentor, and develop a high-performing, engaged team.
- Proven project management expertise, including budgeting, resource allocation, and prioritization.
- Excellent communication and stakeholder management skills to align goals across technical and business teams.
- Familiarity with employee development and fostering a culture of creative problem-solving and innovation.
- Operates with a strong sense of urgency to address critical product issues, ensuring patient safety and regulatory compliance.
