Site Quality Leader

Abbott • Plymouth, MN

1d • $149,300 - $298,700 • Onsite

About The Position

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.

Requirements

• 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

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 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
• 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

Benefits

• 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

What This Job Offers

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