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.

Summary

Incumbent will be a Key Process Owner or SME and provide managerial oversight for activities surrounding operational processes and / or metrics such as Executive Management Review, Global Management Review, Quality System Monitoring, Abbott Monthly Review, Division CAPA, etc. The incumbent is the primary representative during internal and external inspections such as FDA; ISO; and AQR for inquiries surrounding the aforementioned processes and / or metrics.

Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

Functions as the SME for a division quality system; quality subsystem and/or key process.

Identifies and recruits staffing resources to support Divisional scope; multi-site quality system objectives.

Manages Division-level; professional staff to achieve Division goals and strategic initiatives.

Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide.

Assesses processes and / or interprets data to identify emerging signals or trends.

The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.

Position Accountability / Scope

The incumbent will report to the Director, Core Lab Quality Systems and Compliance and will be a direct staff member. It is expected that the individual will interact frequently with Division Management with executive responsibility and therefore requires a high level of competence; confidence and credibility. Strategic and tactical decisions for the Division will be made based upon the information that the individual gathers; provides and/or presents in a management setting.

Qualifications:

Bachelor’s degree

Minimum of 8 years’ experience in medical device industry or other FDA regulated industry experience.

Preferred Qualifications:

Bachelor’s degree in a science; technical and/or engineering discipline

Analytical skills and understanding of tools to interpret data

Mentoring and Coaching a team

Minimum of 2 years Abbott experience