Site Quality Leader

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. WORKING AT ABBOTT : At Abbott, you can do work that matters, grow, and learn, care for yourself and 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 ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists The Opportunity The Site Quality Leader is the senior quality authority for the site and a key member of the Site Leadership Team. The role is accountable for ensuring that all products manufactured, tested, and released from the Plymouth, MN and St. Paul, MN Structural Heart facilities meet global regulatory requirements and conform to the Abbott Structural Heart Quality System. In addition, the position is responsible for establishing and leading the quality strategy, driving regulatory compliance, and maintaining the Quality Management System for finished Structural Heart devices and components manufactured at Minnesota facilities. Establish and implement a site quality strategy aligned with business objectives and regulatory expectations Represent Quality on the Site Leadership Team and embed quality principles into site decision making Promote a proactive quality culture focused on risk management, compliance, and continuous improvement Ensure full compliance with global regulatory standards including EU MDR, FDA QMSR, ISO 13845Maintain continuous inspection readiness and lead regulatory inspections Provide quality oversight for Structural Heart manufacturing processes Lead and develop the site quality organization Location : Plymouth, MN What You’ll Work On Develop and participate in setting quality assurance strategies and regulationsAssess and advise on potential risks, ensures compliance and gives recommendationsTake responsibility for all quality control aspects of the process (e.g., testing, operations, raw materials, production, finished products or services)Lead audits and regulatory inspectionsEstablish quality and reliability standards by studying product and consumer requirements with other members of management and production operators, technicians, and engineersEstablish standards for the disposition of finished products by devising evaluation tests, methods, and proceduresEstablish rework standards by devising inspection and physical testing methods and procedures.Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectivesProvide directions to managers, exempt specialists and non-exempt support in various areas, groups and/or operationsKeep the organization's vision and values at the forefront of decision making and actionBuild strategic partnerships to further departmental and organizational objectivesInteract internally and externally with executive-level management, outside regulatory agencies, customers, vendors and/or suppliersCoordinate across functional areas, business units, and/or geographies to achieve company or area goalsMonitor and ensure compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).Make and execute operational decisions with a strategic perspectiveDirect and control the activities and budget of one or more functional areas, divisions, product groups and/or operationsReview, analyze and present to senior staff and other groups the effectiveness of the Quality SystemRecommend and implement changes to the Quality System because of changing regulations and/or business needsAnalyze data, make decisions or provide recommendations to senior staff regarding quality-related crises (e.g. patient injury due to product malfunction)Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions Experience You'll Bring Required Qualifications Bachelor's or advanced degree in Engineering or related field Minimum 12 years of Medical Device manufacturing experience including significant quality leadership rolesComprehensive understanding of FDA, EU MDR, and global regulatory requirements Proven experience leading and developing quality teams in a medical device manufacturing environment Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities Strong written and verbal communication skills Ability to collaborate effectively across all organizational levels Preferred Qualifications Strong understanding of risk management methodologies and quality tools Proficiency in root cause analysis and implementation of corrective actions Expertise in validation, qualification, and computer system compliance Experience implementing continuous improvement initiatives in a medical device manufacturing setting The base pay for this position is $149,300.00 – $298,700.00. In specific locations, the pay range may vary from the range posted.