Director, Quality Business Support, Software

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

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

THE OPPORTUNITY:

The Director of Technical Quality Support is responsible for directing a team of quality engineers focused on validation and design control of products and processes, including software and technical quality assurance personnel. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight for FDA communications regarding compliance issues. Provide strategic consulting for the division by interfacing directly with the divisions on policy development and deployment. Develop and assess key metrics. Provide senior management with impact of regulatory changes.

This role will provide oversight and management for the software (digital and embedded) and technical quality organization, ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements.

Work effectively with multiple different divisions and medical device technologies.

Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others. A wide degree of creativity and latitude is expected.

Responsible for:

Quality assurance activities for software and firmware development for health care products, including both medical and non-medical applications

Quality assurance activities for hardware development for health care products.

Creating and maintaining an efficient, highly motivated, quality engineering organization.

WHAT YOU’LL WORK ON:

• Provide overall direction and leadership for validation, design and qualification to assure product quality for application software, embedded firmware and hardware products for medical monitoring systems.
• Develop, implement and improve quality policies, processes and procedures, automated systems and reporting systems.
• Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department.
• The incumbent must understand the details of the areas involved. Possess strong leadership skills, an overall knowledge of healthcare industry regulations, ability to effectively negotiate and strong communication skills.
• Provide strategic consulting for programs being developed or implemented.
• Facilitate policy development and deployment throughout the corporation.
• Work to achieve program standardization between businesses.
• Develop and assess metrics for each center.
• Lead and facilitate implementation of new regulations.
• Train our