Sr. Quality Manager - Product Security

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 109,000 colleagues serve people in more than 160 countries.

Our location in Lake County, IL/St Paul, MN currently has an opportunity for a Sr. Quality Manager - Product Security


This role is considered subject matter expert (SME) of BTS PCS (Product Cybersecurity) quality documentation. This includes policies, processes, standards, SOP's, and/or work instructions.

Core Job Responsibilities
  • Work with Product Security and BTS Quality teams to establish and maintain Product Security Policies and Procedures to meet AQR and BTS Quality Systems requirements. This includes review of Product Security processes and advising the teams on implementation of additional controls, as needed, to ensure compliance with Quality Systems and future ability to provide appropriate documentation and evidence during audits.
  • Work with Divisional and Business Unit Quality teams to ensure Product Security processes are appropriately integrated into to Division Quality Systems. This includes ensuring appropriate "hand-offs" exist in each Quality Systems to ensure PCS processes are perform as intended.
  • Build and maintain strategic relationships with BTS, AQR, and division quality groups as needed
  • Experience with quality management systems in a highly regulated environment
  • Thorough understanding Abbott Quality System (AQR) cybersecurity requirements and its impact and relationship to BTS Quality System
  • Manage the risk to business operations by ensuring appropriate actions are taken to address potential non-compliance issues
  • Ability to differentiate quality from non-quality processes and documentation
  • Educate and partner with the business to ensure seamless adoption and understanding of product security shared services
  • Support continuous improvement opportunities through collaboration with key stakeholders
  • Represent PCS in quality related audits if needed
  • Report the performance of the management system
  • Oversee the training of employees on PCS Quality system

Position Accountability & Scope
  • Support integration of new security requirements into Division Quality System and processes.
  • Collaborate with product teams to create and maintain a secure product development lifecycle process to ensure that security requirements/controls can be embedded within the product and development process.
  • Must be able to weigh business needs against security concerns and articulate issues to management.
  • Reporting of security related metrics to Division and Corporate Management

Education and experience, you'll bring
  • BA/BS degree in related field, or equivalent years of related experience
  • 5+ years' experience working in regulated environment with Quality Management Systems
  • Understanding of Cyber security is preferred

Supervisory / Management Responsibilities

No direct or indirect supervisory responsibility


At Abbott, you can have a good job that can grow into a great career. We offer:
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
  • Paid time off
  • 401(k) retirement savings with a generous company match
  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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