Site Quality Leader

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

• 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

• 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

• 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 

In specific locations, the pay range may vary from the range posted.