Site Quality Leader

Abbott Laboratories • Plymouth, MN

5d • $149,300 - $298,700 • Onsite

About The Position

The Site Quality Leader is the senior quality authority and a key member of the Site Leadership Team for Abbott Structural Heart facilities in Plymouth and St. Paul, Minnesota. The role ensures that products manufactured, tested, and released at these facilities meet global regulatory requirements and comply with the Abbott Structural Heart Quality System. The leader establishes and directs the site quality strategy, drives regulatory compliance, and maintains the Quality Management System for finished Structural Heart devices and components manufactured at the Minnesota facilities.

The position provides quality oversight for manufacturing processes, maintains inspection readiness, and leads regulatory inspections and audits. It leads and develops the site quality organization, promotes a proactive culture of risk management and continuous improvement, and advises on quality risks and responses. The role also directs quality-related operational activities and budgets, reviews the effectiveness of the Quality System, and communicates quality policies and strategies across the organization. The listed location is Plymouth, MN.

Requirements

• Bachelor's or advanced degree in Engineering or a related field.
• At least 12 years of medical device manufacturing experience, including significant quality leadership roles.
• Comprehensive understanding of FDA, EU MDR, and global regulatory requirements.
• Demonstrated experience leading and developing quality teams in a medical device manufacturing environment.
• Expertise managing quality systems, including CAPA, change control, deviations, complaints, and document control.
• Experience managing regulatory inspections and customer audits, and serving as the primary quality interface with authorities.
• Strong written and verbal communication skills.
• Ability to collaborate effectively across all organizational levels.

Nice To Haves

• 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.

Responsibilities

• Establish and implement a site quality strategy aligned with business objectives and regulatory expectations.
• Represent Quality on the Site Leadership Team and incorporate quality principles into site decisions.
• Promote a proactive quality culture focused on risk management, compliance, and continuous improvement.
• Ensure compliance with global regulatory standards, including EU MDR, FDA QMSR, and ISO 13845.
• Maintain continuous inspection readiness and lead regulatory inspections and audits.
• Provide quality oversight for Structural Heart manufacturing processes.
• Lead and develop the site quality organization.
• Develop and participate in setting quality assurance strategies and regulations.
• Assess potential risks, advise on them, ensure compliance, and make recommendations.
• Oversee quality control across processes, including testing, operations, raw materials, production, and finished products or services.
• Establish quality and reliability standards in collaboration with management, production operators, technicians, and engineers.
• Establish standards for finished-product disposition, including evaluation tests, methods, and procedures.
• Establish rework standards through inspection and physical testing methods and procedures.
• Provide direction to managers, exempt specialists, and non-exempt support across relevant areas and operations.
• Keep organizational vision and values central to decisions and actions, and foster an inclusive workplace where people can contribute fully.
• Build strategic partnerships and coordinate across functions, business units, and geographies to achieve organizational goals.
• Interact with executive management, regulatory agencies, customers, vendors, and suppliers.
• Monitor and ensure compliance with company policies and procedures, including applicable FDA, BSI, and EEO regulations.
• Make and execute operational decisions with a strategic perspective, and direct and control activities and budgets for one or more functional areas or operations.
• Review, analyze, and present the effectiveness of the Quality System to senior staff and other groups.
• Recommend and implement Quality System changes in response to regulatory changes or business needs.
• Analyze data and make decisions or recommendations to senior staff regarding quality-related crises, such as patient injury caused by product malfunction.
• Communicate quality policies, strategies, and procedures through written documents, presentations, and discussions.

Benefits

• Career development opportunities with an international company.
• Free medical coverage for employees through the Health Investment Plan (HIP) PPO.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, providing an affordable and convenient path to a bachelor's degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior