Abbott
healthcare
QualityEngineerI
“Quality Engineer I at Abbott. Skills: Quality Engineer, process control, CAPA, product development, manufacturing processes. Identify and implement effective process control systems. Lead in the implementation of assurances, process controls, and CAPA systems”
What You'll Achieve.
assure new or modified products conform to requirements; establish compliance with the quality system; protecting patient/user safety; meeting business needs; support new product development projects; support sustainability of commercially released product; meet daily production schedules while enhancing productivity and product quality
Industry & Context.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Travel: Yes, 10 % of the Time, Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
What They're Looking For.
Must Have
Bachelor's degree in engineering or Technical Field or an equivalent combination of education and work experience, 0-2 years Engineering experience, 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, verbal and written communications with ability to effectively communicate at multiple levels in the organization, Multitasks, prioritizes, and meets deadlines in timely manner, organizational and follow-up skills, as well as attention to detail
Nice to Have
Prior medical device experience preferred, Experience working in a broader enterprise/cross-division business unit model preferred, CAPA owner or a key cross-functional team member leading a CAPA project, Use of quality tools/methodologies, Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971, Risk management, post market surveillance, and manufacturing analysis
What You'll Do.
Identify and implement effective process control systems
Lead in the implementation of assurances
Assist in the development and execution of streamlined business systems
systematic problem-solving methodologies
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodologies
Lead the investigation
resolution and prevention of product and process non-conformances
Participate in or lead teams in supporting quality disciplines
Lead in the completion and maintenance of risk analysis
Work with design engineering in the completion of product verification and validation
Work with microbiology to ensure appropriate environmental monitoring
Support all Company initiatives as identified by management
Complies with U.S. Food and Drug Administration (FDA) regulations
other regulatory requirements
How You'll Work.
Team & Collaboration
maintaining a collaborative partnership with cross-functional team members; Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member); Work with design engineering; Work with microbiology; Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Communication Scope
verbal and written communications with ability to effectively communicate at multiple levels in the organization
Process & Methodology
Lead CAPA project
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