Abbott Quality Program Manager- Design Quality in Abbott Park, Illinois
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 103,000 colleagues serve people in more than 160 countries.
Primary Job Function:
The function of the Quality Program Manager – Design Quality is to provide corporate-wide leadership, direction, oversight, and project management covering Abbott’s Quality System. The activities expected of this position include providing general division / business support and consulting on matters of regulatory compliance and application of quality systems elements.
The Quality Program Manager – Design Quality role will serve as a subject matter expert (SME) in the area of design controls. The candidate must possess knowledge and experience of the Quality System requirements relative to design controls and will serve as a technical expert in design and development processes. The SME must be able to apply all global requirements, such as International Organization for Standardization (ISO), for the design and development activities across multiple manufacturing sites/division, business types (i.e. devices, pharma, nutrition), and product complexities.
The candidate must be able to:
Monitor, lead, and facilitate implementation of new or changing regulatory requirements for design and development activities throughout the corporation.
Promote and lead program consistency and standardization of design controls and practices between Abbott businesses and divisions.
Provide technical reviews and make recommendations related to the design controls elements (e.g. design inputs, design outputs, design verifications, etc.).
Assist all Abbott businesses/divisions with design and development improvement initiatives, including design controls process improvements, new product development, legacy product remediation, etc.).
Develop design quality related training programs, seminars, workshops, and other appropriate meetings or functions to share information and reinforce the application of design requirements and program objectives/strategies.
Create and analyze various design quality and technical data to facilitate independent and risk-based decision making for design-related issues that may result in adverse regulatory impact to the corporation.
Apply the fundamentals of risk management throughout a products life cycle.
Understand other Quality Systems elements, in particular the sub-parts that both impact and/or are impacted by design controls.
Effectively communicate at all levels of an organization, especially at the senior leadership levels.
Travel up to 75%, both domestic and international.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Lead global committees and teams
Provide direct business/division support
Participation in industry groups
Improve the effectiveness of the Abbott Quality System, including monitoring, trending and analysis of Abbott compliance performance
Act as a change agent for incorporating best practice methods
Position Accountability / Scope:
The scope of this position is Abbott-wide, covering all Abbott divisions / businesses.
This position manages multiple global projects.
Given the nature of the projects as they relate to regulatory compliance, the financial consequences for adverse regulatory findings or delayed product approval initiatives range from $10MM to $50MM.
This position manages confidential information across the project lifecycle.
Significant interaction with executive management with accountability for assigned projects.
4-year degree in technical or science related discipline.
Minimum Experience / Training Required:
Managerial/Supervisory/Team Lead Experience - 2 years
Design Quality and/or Research & Development and/or Quality Assurance and/or Compliance and/or Analytical Laboratories and/or Manufacturing and/or Operations and/or Engineering - 10 years (design quality and R&D experience preferred)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org