Senior Manager, Quality Engineering Post-Market - Newark. DE Newark, DE, United States **Elevate Quality and Customer Satisfaction as Our Senior Manager, Post-Market Quality Engineering!** Are you passionate about driving product excellence and enhancing customer satisfaction? We are seeking a dynamic and experienced Senior Manager for Post-Market Quality Engineering to join our team in Newark, Delaware. Lead impactful quality evaluations and investigations in this pivotal role. **What to Expect:** As a Senior Manager, you will lead activities related to product quality evaluations, investigations, and root cause analyses based on post-market feedback and field complaints. Your strategic vision will be essential in setting and monitoring key performance indicators, ensuring alignment with our high standards, and taking necessary actions as required. By analyzing data and evaluating strategic impacts, you will effectively prioritize schedules to drive operational success. Focusing on customer quality, you will build strong relationships with our sales and service teams, providing on-site support and ensuring customer satisfaction. You will select, develop, and evaluate top talent to ensure efficient operations, fostering a culture of continuous improvement and excellence. This role offers you the opportunity to maintain and elevate our product quality standards and enhance customer satisfaction. If you have a keen eye for detail, a strategic mindset, and a passion for quality assurance, we want to hear from you. Join us and lead the charge in setting new benchmarks for quality and customer support. **Responsibilities:** + Build and lead a customer-facing quality engineering team that interacts with field teams and customers by participating in site visits and attending sales and service council meetings. + Own customer/field team-facing quality communication, including customer memos and quality updates. + Lead quick root-cause analyses and effective resolutions to product quality issues, including ship holds and field actions, while communicating regularly with key stakeholders. + Ensure accurate and timely processing of complaints and adverse event reporting to regulatory bodies. + Collaborate with R&D, Manufacturing, Service, and Supplier Quality to deliver effective product quality improvements or fixes expediently. + Conduct health risk assessments on complaints, CAPAs/NCs, ship holds, and recall decisions. + Support inspections by regulatory bodies regarding documentation of product quality investigations, CAPAs, NCs, and other post-market matters. + Present trends from investigation findings and recommendations for improvement to management. + Own post-market quality data for responsible products. + Develop procedures, tools, and techniques to aid in product investigations. + Collaborate with technical groups to identify product or process improvement opportunities based on surveillance findings. + Drive engagement to ensure personnel have clear expectations, appropriate tools, and opportunities for growth and development. + Provide post-market input to new product development teams to ensure key quality considerations are scoped into future product designs and testing. **Qualifications and Skills:** **Education and Experience:** + 8-10+ years in the medical device industry with a Bachelor’s Degree in an engineering or scientific discipline (Mechanical, Electrical, etc.). **Skills:** + Knowledge of Regulation 21 CFR Part 820, Part 803, and applicable international quality standards and regulations, including ISO 13485:2016, Canadian MDR, and EU Medical Device Regulation. + Prior management experience in a medical device, pharmaceutical, or heavily regulated industry. + Strong analytical skills, including trend and statistical analysis. + Strong leadership and interpersonal skills with the ability to develop and manage high-performing teams. + Familiarity with employee development and mentoring processes. + Demonstrates independent decision-making and prioritization skills. **Beneficial:** + Experience with Oracle & Agile. + PMP Certification. + Lean-Six Sigma Green or Black Belt Certification. **Why Join Hologic?** We are committed to making Hologic a company where top talent comes to grow. We provide comprehensive training and continued development throughout your career. We offer a competitive salary and annual bonus scheme, which one of our talent partners can discuss in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you! **Compensation:** The annualized base salary range for this role is $131,400 - $219,000 and is bonus eligible. Final compensation packages will depend on factors including relevant experience, skillset, knowledge, geography, 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. 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-LB2