Site Quality Leader

Abbott; United States; On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Free medical coverage

Tuition reimbursement

Strong retirement savings plan

Education benefit

Job summary

Abbott is seeking a Site Quality Leader to oversee quality for the Plymouth, MN and St. Paul, MN Structural Heart facilities. You will drive the Quality Management System, regulatory compliance and a proactive quality culture across manufacturing and release processes.

Lead a team of quality professionals, align quality strategy with business goals, and prepare for regulatory inspections while ensuring product safety and regulatory readiness.

Qualifications

• Bachelor's or advanced degree in Engineering or related field.
• Minimum 12 years of Medical Device manufacturing experience including significant quality leadership roles.

Responsibilities

• Establish and implement a site quality strategy aligned with regulatory expectations.
• Represent Quality on Site Leadership Team and embed quality into decision making.
• Promote a proactive quality culture focused on risk management and continuous improvement.
• Maintain compliance with EU MDR, FDA QMSR, ISO standards and inspections readiness.
• Lead and develop the site quality organization and oversee manufacturing processes.

Skills

Quality leadership

Regulatory compliance

Risk management

Quality systems

Audits

Education

Bachelor's degree in Engineering or related field

Job description

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.

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 policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).
• Make and execute operational decisions with a strategic perspective
• Direct and control the activities and budget of one or more functional areas, divisions, product groups and/or operations
• Review, analyze and present to senior staff and other groups the effectiveness of the Quality System
• Recommend and implement changes to the Quality System because of changing regulations and/or business needs
• Analyze 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 roles
• Comprehensive u