Abbott Senior Quality Professional CAPA in Des Plaines, Illinois
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
Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes.
Core Job Responsibilities
Responsible for implementing and maintaining the effectiveness of the quality system.
- General - Defines project goals and milestones. Responsible for timely project completion. Provides solutions to a wide range of difficult problems. Ensures that solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. May lead projects with cross-functional or broader scope. Interacts effectively with employees; manager; and cross-functional peers. May represent own team while on cross-functional project teams with other functional leaders. Communicates confidently and
effectively with management; peers; and key stakeholders. Implements tactical solutions related to assignment. Able to contribute functional skills and expertise broadly. Directly influences project direction and scope. Scope includes one or more QA functions; with general knowledge of other related disciplines. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors. Strong interpersonal and collaboration skills. Delivers on commitments – takes accountability for failure
Quality System Compliance - Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate. Ensures adherence and maintains the effectiveness of the Quality System; including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
CAPA Program – Capable of leading investigations of quality issues or mentoring CAPA teams with little management oversight. Provides solutions to a wide range of problems. Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Ensures compliant documentation in area of responsibility. Represents the site as a CAPA SME or Process Community member. Responsible for coordinating the CAPA Review Board and monitoring related activities. Administers support for Trackwise CAPA records and report management.
Position Accountability / Scope
Receives general direction and exercises considerable discretion to own work detail. Recommends possible solutions. Ensures compliant documentation; carrying out tasks related to area of responsibility with management oversight. Decisions may have short and long-term impact.
Apprenticeship or Bachelor’s degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience.
Minimum Experience / Training Required
At least 5 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
Preferred experience in the Healthcare industry. CAPA and Track wise experience desirable.
Has a history of completing successful projects and driving positive compliance outcomes.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org