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:
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 of
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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 around the world 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 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 13845
Maintain 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 regulations
Assess and advise on potential risks, ensures compliance and gives recommendations
Take responsibility for all quality control aspects of the process (e.g., testing, operations, raw materials, production, finished products or services)
Lead audits and regulatory inspections
Establish quality and reliability standards by studying product and consumer requirements with other members of management and production operators, technicians, and engineers
Establish standards for the disposition of finished products by devising evaluation tests, methods, and procedures
Establish 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 objectives
Provide directions to managers, exempt specialists and non-exempt support in various areas, groups and/or operations
Keep the organization's vision and values at the forefront of decision making and action
Build strategic partnerships to further departmental and organizational objectives
Interact internally and externally with executive-level management, outside regulatory agencies, customers, vendors and/or suppliers
Coordinate across functional areas, business units, and/or geographies to achieve company or area goals
Monitor and ensure compliance with company…