Director, Digital Health Quality

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.

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. Youâll 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 bachelorâs 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.

The Opportunity

This position works out of our Lake Forest, IL location in the Core Lab Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. The Director, Digital Health Quality â will establish and maintain strategies, policies, and processes within the Digital Health area covering a broad range of products including non-medical products, but also products regulated as medical devices. They will play a key strategic role in ensuring the quality system meets the needs of the business as well as any applicable regulatory bodies, and evolves as the digital space evolves. They role will interact with numerous global functions to represent the voice of Quality in key strategic discussions and will have the ability to contribute to outcomes that meet business needs. 

What Youâll Work On

• Provide global strategic direction and tactical assistance for the digital health area and support on matters related to regulations, quality systems and quality issues.⯠This role has accountability for complying with local and global Quality System requirements as applicable to the product portfolio.

• Provide direction to the Digital Health organization in the development, implementation and maintenance of a Quality System appropriate for the functions performed noting that some products supported are not medical devices while others are regulated as so.

• Provide diligent and fact-based communication to Management team, Business Unit leaders, peers, and quality, regulatory and other functional team members in the organization.  Assure Quality provides technical support and services to Engineering, Research & Development and other cross-functional groups involved in developing, launching, and maintaining digital products and e-Services delivery. 

• Support all Divisional initiatives as identified by management and in support of Quality Management Systems (QMS), Quality Management reviews, and other regulatory requirements and programs as prioritized by leadership. 

• Work as a member of the management team to develop and monitor quality objectives., appropriate Quality KPIs, and provide oversight of Quality processes. 

• Serve as the Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise to represent the Digital Health organization as the main interface with necessary regulatory bodies and external auditors.  

• Support development of QA personnel through interaction and training to ensure personnel are informed, and that business interactions and processes comply to applicable laws and regulations.

• Implement Global Standards / Procedures and e-enterprise systems as needed to support the quality system.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâs policies and practices.

• Understand and be aware of the quality consequences that may occur from the improper performance of their specific job. Have awareness of potential defects that may occur in their area of responsibility, and across the business processes of the organization; including product design, verification and validation, manufacturing and testing activities. 

• Accountable for establishing appropriate training for the organization, including QS training and ensuring requirements of applicable regulations are encompassed in local procedures. 

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's Degree in related field, or an equivalent combination of education and work experience.

• Minimum of 10 years related work experience.

• Experience leading teams across functions and managing in a matrixed environment. Experience leading across geographically diverse environment.

• Demonstrated strong leadership skills and ability to influence decisions. Demonstrated ability to communicate effectively both verbally and written. â

• Ability to travel up to 25%, including internationally 

• Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.

Preferred Qualifications

• B.S/B.A.in Software Engineering/Development, Engineering, Technical Discipline or Science. Master's degree preferred.

• 10+ years combined experience in science/engineering/technical industry.

• 3 plus years management experience.

• 5+ years in Quality or Software Development/Engineering.

• Experience in development of products (software and apps preferred) including knowledge of agile design processes and best practices.

• Experience with industry best practices for software development/management.

• Experience with complex problems requiring critical thinking. Experience interacting with Sr. level management.

• Work experience in quality desired with at least 3+ years management of demonstrated compliance excellence, value improvement, risk reduction, and cost containment. Class III or II medical device background.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $143,300.00 â $286,700.00. In specific locations, the pay range may vary from the range posted.