Abbott is a global healthcare leader that helps people live more fully at all stages of life. The position of Senior Specialist Quality Assurance is within their Infectious Disease Developed Markets business unit, responsible for supporting the efficient functioning of Quality Assurance and the Quality System.
Responsible for reviewing and approving non-product software lifecycle deliverables
Participate in Quality System processes, which may include training, corrective action and preventive action (CAPA) activities, quality audits, and non-software product validation
Apply established software quality and engineering methods to the investigation and solution of software quality problems
Assist in determining quality attributes and requirements; may provide technical assistance
Utilize quality management techniques to perform investigations and facilitate solutions
Responsible for completing documentation in a timely manner and in accordance with business standards
Participate on cross-functional teams
Other tasks and duties as assigned
Understand and comply with applicable Quality System policies, procedures, and guidelines
Works under the supervision of more experienced staff who review results for overall accuracy, completeness, and sound judgment
Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors
Responsible for meeting established objectives and goals
Drives functional performance to ensure that cross-functional standards and expectations are met
May assist in the training of personnel as directed by management
Qualification
Required
Bachelor's degree, or equivalent combination of experience and education
2 years of experience in a manufacturing environment
Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices
Knowledge of ISO 13485 standard
Knowledge of quality management techniques and application
Ability to clearly, concisely and accurately convey communications
Ability to form and develop interpersonal, professional relationships
Display socially and professionally appropriate behavior
Ability to work independently and in groups
Ability to work cross-functionally
Demonstrated initiative and problem-solving skills
Critical-thinking skills
Ability or aptitude to use various types of databases and other computer software
Strong organizational skills
Ability to prioritize
Ability to multitask
Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives
Ability to quickly gain knowledge, understanding or skills and is willing to learn
Preferred
Hands-on experience and/or working knowledge of non-product software and software development lifecycle (SDLC) is preferred
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
