Abbott Engineer I, Quality Assurance in Plano, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
Execute and provide on-time completion of Quality Assurance (QA) engineering deliverables.
Support decision making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
Support key stakeholders with developing and maintaining QA procedures, forms, and systems.
Support QA system training.
Support product review and analysis for QA activities.
Maintain databases and record storage for QA systems.
Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
Participate in meetings and communications for QA system information, concerns, and updates.
Support QA data analysis, trending, and reporting. Publish weekly, monthly, and quarterly metrics.
Track manufacturing related complaints in alignment with SJM goals.
Seeks out information with direction and able support other members of the organization on QA practices.
Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
Support presentation of CAPA System to internal and external auditors. Suport investigation and resolution of system nonconformances and concerns (defined during internal and external audits).
As appropriate, participates in the completion of risk assessment, as related to QA systems.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor level degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
0-2 years technical experience
Previous Quality assurance/engineering experience preferred
Solid communication and interpersonal skills
Advanced computer skills, including statistical/data analysis and report writing skills
Prior medical device experience preferred
Root cause analysis/problem solving training and experience preferred.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%, including internationally.
Ability to maintain regular and predictable attendance.
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 email@example.com