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.
Primary Job Function
Leads root cause investigations related to supplied material nonconformances, drives material dispositions and risk mitigations. Develops and improves acceptance criteria, inspection methods and process efficiencies at incoming inspection. Monitors and analyzes supplier performance metrics to drive supplier corrective actions, improve manufacturing yield issues and/or reduce/eliminate field failures. Plans and executes supplier audits and address improvements needed to the supplier's quality system to improve the quality and service of incoming material.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Analyzes and investigates material defects related to complex issues discovered at incoming inspection, manufacturing and in the field using problem solving methodologies to drive to root cause. Determines and executes appropriate material disposition strategies to support commercial demands. Provides guidance in root cause investigations and CAPA's.
2. Leads moderately complex initiatives to eliminate/reduce nonconformances, improve efficiencies and drive down cost in the organization and at the supplier. Collaborates with suppliers to implement corrective actions through the CAPA process to eliminate/reduce future nonconformances.
3. Acts as a liaison between Abbott and suppliers for cross functional projects and manages supplier driven activities.
4. Maintains component specifications for approved components. Generates and maintains incoming inspection procedures. Trains inspectors to respective procedures.
5. Develops and/or sources inspection tools and equipment. Qualifies tool and equipment. Plans and executes test method validations including analysis of data using statistical techniques.
6. Provides support for material qualifications of new components, second sourcing projects and changes to approved components.
7. Plans and executes supplier audits. Manages supplier investigations and corrective actions related to supplier audit findings.
8. Monitors, communicates and improves supplier's performance.
Supervisory / Management Responsibilities
Position Accountability / Scope
Influence/Leadership: Establishes and cultivates an extensive network of support to facilitate completion of assignments . Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel . Leads a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts with suppliers in a professional manner.
Planning/Organization: Plans, organizes, and establish priorities of daily work routine, project tasks and work assignments to meet planned due dates and timelines . Ability to manage a variety of due dates simultaneously.
Decision Making/Impact: Exercises judgment using a risk-based approach when necessary in proposing innovative, practical methods to achieve problem resolution . Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
Bachelor's degree plus 5 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Minimum Experience / Training Required
Technical/Business Knowledge: Good organizational and project management skills. Ability to work independently and in groups; ability to work cross-functionally. Wide application of technical principles, practices, and procedures. Ability to independently execute problem solving methodologies to obtain root cause and propose corrective and/or preventative actions to eliminate/reduce future nonconformances. Strong understanding of business unit function and cross group dependencies/relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Cognitive Skills: Demonstrates initiative and problem-solving skills; critical-thinking skills. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.