Abbott Quality Systems Engineer II in Minnetonka, Minnesota
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.
• 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.
• Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues.
• 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/systems 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