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.

REQUIRED QUALIFICATIONS

• Bachelors degree or equivalent experience is required.
• Equivalent combination of education and mins of 5 yrs of work experience will be considered.
• Previous experience with complaints investigations in a regulated environment and knowledge of the FDA/QSR regulation and ISO 13485 standard is required.
• An understanding of ADC product is ideal. Must be able to effectively lead a large staff of non-exempt employees including full-time and contract workers.
• Excellent communications skills are required as there may be interaction with other functions in ADC such as Customer Support, R&D, and Manufacturing.
• Must also be able to act autonomously and make decisions regarding the need to pursue further investigation vs. bring closure to an investigation.
• Complaints investigations are a primary focus of corporate and FDA audits.
• Investigations that are not conducted or documented properly could lead to an observation for ADC.

PREFERRED QUALIFICATIONS

• Preferred experience in the Healthcare industry.
• Has a history of completing successful projects and driving positive compliance outcomes.

• The Sr. Specialist Quality Assurance leads complaint investigation activities with regard to blood glucose meters.
• Ensures that complaints investigations are done according to procedures in a timely manner.
• Monitors people and processes with an eye towards improving the efficiency of the investigations that are performed.
• Responsible for identifying any trends in product complaints that are found during investigations.
• Responsible for tracking all returned product, calibration and proper validation of all test equipment within the lab.
• Assists Lab Supervisor in performance evaluations as well as administrative duties.
• Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management