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 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 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.