Are you passionate about delivering exceptional product quality and ensuring customer satisfaction in a regulated industry? We're seeking a Senior Manager, Post-Market Quality to lead critical post-market activities, resolve product issues, and drive continuous improvement in collaboration with cross-functional teams. In this role, you'll oversee product complaint management, adverse event reporting, and root cause analysis, ensuring compliance with regulatory standards such as FDA, ISO 13485, and MDR. You'll act as a customer advocate, engaging directly with customers and field teams to address quality concerns and improve experiences. Additionally, you'll lead a team of Quality Engineers, foster a culture of accountability, and translate post-market data into actionable improvements for both products and processes. If you're ready to make a meaningful impact in a global organization focused on quality, innovation, and customer success, apply today! Knowledge * Strong understanding of Medical Device Regulations, including FDA requirements (21 CFR Part 820, Part 803), ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation (MDR). * Expertise in post-market surveillance activities such as complaint handling, adverse event reporting, trending, and signal detection. * In-depth knowledge of Health Risk Assessments, CAPA processes, and root cause analysis methodologies. * Familiarity with statistical analysis tools and techniques for quality data evaluation. * Awareness of industry advancements and best practices in medical device quality management. Skills * Exceptional leadership and team management skills, including mentoring and developing high-performing teams. * Advanced problem-solving and analytical capabilities for identifying and resolving quality issues. * Strong interpersonal and collaboration skills to manage cross-functional relationships effectively. * Ability to generate, analyze, and present post-market data insights to drive decision-making and improvements. * Independent decision-making and prioritization abilities to address urgent challenges and deliver results. Behaviors * Proactively engages with customers, prioritizing their needs and delivering exceptional experiences. * Builds strong relationships across departments to align goals and drive shared success. * Takes ownership of post-market quality issues and ensures timely, effective resolutions. * Acts decisively to address critical challenges while maintaining focus on safety and compliance. * Strives for excellence by identifying opportunities to enhance processes, products, and team performance. * Stays current with industry trends and applies insights to improve quality practices. Experience * 10+ years of experience in quality management roles with a Bachelor's degree, 7+ years with a Master's, or 5+ years with a PhD. * Proven leadership experience in medical device, pharmaceutical, or other regulated industries. * Demonstrated success in managing post-market quality activities, including complaint handling, adverse event reporting, and CAPA. * Experience working directly with customers and resolving field quality issues. * Background in leading quality teams and fostering a culture of excellence. * Beneficial: * Experience with Oracle and Agile systems. * PMP Certification. * Lean-Six Sigma Green or Black Belt Certification. * Experience working with capital equipment in a healthcare setting. The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position. 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 $132,100 - $220,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1