Manager Quality Assurance (31025044)
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 113,000 colleagues serve people in more than 160 countries.
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
The position of Manager, Quality Assurance is within our Toxicology business unit located in Santa Rosa. This role provides direction and oversight of Lab Developed Tests (LDTs) in addition to new test method development. Must work well with others in the organization to ensure the above listed processes are compliant to internal and external requirements. This job description will be reviewed periodically and is subject to change by management.
Complete initial licensure applications and renewal of all applicable site licenses
Ensure all laboratories within the assigned area(s) maintain current federal, state and local licensure and accreditations, as applicable
Overall responsibility to assure that the Nonconformance (QI’s) and Corrective and Preventive Action (CAPA) processes and procedures are in alignment with FDA and ISO requirements as well as ARDx global policies.
Assures that the Quality continuous improvement processes (NC’s and CAPA’s) meets ARDx metric expectations for key metrics and assure that when metrics are not achieved that clear plans for improvements are implemented and achieved.
Will be a part of the team that interfaces with external audits and will serve as the subject matter expert for CAPA and Non-conformance, frequently communicating with external legal or regulatory bodies.
Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, CLIA, CAP, ABFT and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships
Carries out duties in compliance with established business policies
Other duties as assigned, according to the changing needs of the business
MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:
BS/BA degree in a science related or technical field
Five to seven years related experience working in a professional environment where compliance was of vital importance and management experience
Knowledge of Quality System Regulations, ISO 13485, CLIA, CAP, ABFT, ISO 17025.
Working knowledge of Quality Assurance in a toxicology/clinical lab environment.
Six Sigma green or black belt certification.
Strong management skills with proven leadership and team building skills.
Motivates the team by understanding unique needs and engages in frequent conversations and performance coaching.
Holds others accountable by focusing on the right metrics, tracking results and creating transparent reviews
Excellent organization skills — must be able to manage a large number of simultaneous projects.
Attention to detail — must have precision in work completed, especially as it relates to understanding and documenting complex quality issues.
Attracts, selects, develops and manages talent for higher levels of performance.
Assesses issues thoroughly and solves complex problems; removes roadblocks for the team
Excellent writing skills — must be able to summarize complex issues in a clear, succinct and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
Strong communication, problem solving and motivational skills.
Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.
Ability to interact effectively with all levels of the organization, engage resources and perform multiple tasks in a fast-paced environment.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.