Sr. Manager, Quality Engineering

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Senior Manager, Quality Engineering Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position works out of our St Paul MN OR Plymouth, MN location for our Electrophysiology business. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. We are seeking a strategic and influential Senior Manager, Quality Engineering & Analytics to lead quality systems performance, quality data analytics, and continuous improvement initiatives across the organization. This leader will be responsible for transforming quality data into actionable business insights, driving compliance, and building a long-term vision for how quality data can be leveraged to improve product performance, patient safety, and business outcomes. This role goes beyond traditional quality management. The successful candidate will lead a team responsible for analyzing and integrating data from complaints, CAPA, management reviews, post-market surveillance, quality metrics, manufacturing performance, and commercial data to identify trends, mitigate risk, and shape future-state quality strategies. The ideal candidate combines strong quality leadership experience within the medical device industry with a passion for analytics, systems improvement, and organizational influence. What You'll Work On Quality Strategy & Leadership Provide strategic leadership and oversight for Quality Engineering and Quality Analytics functions. Establish a vision for the future of quality data management, analytics, and reporting capabilities across the business. Lead the development and execution of quality strategies that support product quality, patient safety, compliance, and operational excellence. Serve as a key member of the quality leadership team, influencing business decisions through data-driven insights. Build organizational capability by coaching, mentoring, and developing high-performing quality professionals. Quality Data Analytics & Business Insights Lead the collection, analysis, interpretation, and presentation of quality performance data across the organization. Oversee management reviews, monthly quality reviews, complaint trending, CAPA effectiveness monitoring, post-market data analysis, and key quality performance indicators. Integrate data from manufacturing, commercial sales, complaints, risk management, and quality systems to identify emerging trends and opportunities. Develop executive-level dashboards and reporting that provide clear visibility into product quality and business performance. Drive continuous improvement of reporting systems, automation tools, and analytics capabilities. Create a roadmap for future-state quality analytics capabilities, leveraging data to proactively identify and mitigate risks. Quality Systems & Compliance Ensure manufacturing quality system requirements are effectively established, maintained, and continuously improved. Monitor and report quality system performance to executive leadership. Lead quality system reviews and ensure compliance with applicable domestic and international regulations. Provide oversight of CAPA processes, complaints management, nonconformance management, and quality system effectiveness. Drive proactive compliance initiatives across quality operations and business functions. Lead initiatives to improve quality processes, procedures, and automated quality systems. Regulatory & Audit Leadership Serve as a primary quality representative during external regulatory inspections and audits. Ensure readiness for FDA, notified body, and international regulatory inspections. Partner with Regulatory Affairs, Manufacturing, Engineering, and Operations leadership to address compliance risks and regulatory requirements. Ensure quality activities comply with FDA regulations, ISO 13485, and other applicable global standards. Cross-Functional Collaboration Partner with Manufacturing, Engineering, Product Development, Regulatory Affairs, Risk Management, Clinical, and Commercial teams to drive business outcomes. Influence senior stakeholders and cross-functional leaders to implement quality improvements and risk mitigation strategies. Lead enterprise-level quality initiatives across functions, sites, and business units. Translate complex quality data into meaningful business recommendations that drive action. People Leadership Recruit, develop, and retain diverse, high-performing teams. Establish performance goals aligned with organizational objectives. Foster a culture of accountability, collaboration, innovation, and continuous improvement. Provide ongoing coaching and career development for team members. Create an environment focused on patient safety, quality excellence, and business partnership. Required Qualifications Bachelor's degree in Engineering, Science, Quality, or related technical discipline. 10+ years of progressive experience in Quality Engineering, Quality Systems, Quality Assurance, or related functions within the medical device or highly regulated industry. 5+ years of people leadership experience managing technical or quality teams. Demonstrated experience leading quality systems and quality compliance programs in Class II or Class III medical device environments. Experience with complaint handling, CAPA management, management reviews, quality metrics, and post-market quality systems. Strong analytical background with experience leveraging data to drive business decisions. Knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, GMP requirements, and global quality standards. Proven ability to influence stakeholders and lead cross-functional initiatives in a matrixed environment. Exceptional communication, presentation, and executive stakeholder management skills. Strong project management and organizational leadership capabilities. Preferred Qualifications Advanced degree in Engineering, Quality, Data Analytics, Business, or related field. Experience building or modernizing quality analytics platforms, dashboards, and automated reporting systems. Knowledge of statistical methods, data visualization tools, and quality data management systems. ASQ Certifications (CQE, CQA, CMQ/OE) preferred. Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification. Experience supporting global quality operations and multi-site organizations. Experience working closely with commercial and post-market surveillance teams to connect customer feedback with quality strategy. What Success Looks Like In this role, you will: Establish a clear vision for the futur