Abbott
Healthcare
QualityEngineerI
Neural analysis suggests this role is
optimal for Entry candidates.
“Quality Engineer I at Abbott. Skills: Quality engineering, Process control, Problem-solving, Risk analysis. Identify process control systems. Implement process control systems”
Industry & Context.
Problem-solving methodologies; Root cause analysis; Data-driven decision making
5% travel, Continuous sitting, Keyboard use
What They're Looking For.
Must Have
BS degree in Engineering or Technical Field, 0-2 years of experience, 2 years of Engineering experience, Demonstrated use of Quality tools/methodologies, Detailed knowledge of FDA, Detailed knowledge of GMP, Detailed knowledge of ISO 13485, Detailed knowledge of ISO 14971, Solid communication skills, Solid interpersonal skills, Project management skills, Leadership skills, Ability to lead multi-departmental project teams, Ability to resolve quality issues, Advanced computer skills, Statistical/data analysis skills, Report writing skills, Ability to work in a highly matrixed environment, Ability to work in a geographically diverse environment, Ability to work within a team, Ability to work as an individual contributor, Ability to work in a fast-paced environment, Ability to work in a changing environment, Ability to leverage others for projects, Ability to engage others for projects, Verbal communications, Written communications, Ability to communicate at multiple levels, Multitasks, Prioritizes, Meets deadlines, Organizational skills, Follow-up skills, Attention to detail
Nice to Have
Masters Degree preferred, Prior medical device experience preferred, Experience implementing Six Sigma, Experience implementing Lean Manufacturing, ASQ CQE certification preferred, Other certifications preferred, Experience working in a broader enterprise model preferred, Experience working in a cross-division business unit model preferred
What You'll Do.
Identify process control systems
Implement process control systems
Lead assurance implementation
Lead process control implementation
Lead CAPA systems implementation
Assist in business systems development
Assist in business systems execution
Apply problem-solving methodologies
Identify quality issues
Prioritize quality issues
Communicate quality issues
Resolve quality issues
Document experiment plans
Document experiment results
Lead CTQ parameter control
Lead CTQ parameter monitoring
Lead product improvement methodologies
Lead process improvement methodologies
Lead non-conformance investigation
Lead non-conformance resolution
Lead non-conformance prevention
Participate in quality teams
Represent Quality function
Complete risk analysis
Maintain risk analysis
Work with design engineering
Work with microbiology
Ensure environmental monitoring
Consider microbiology requirements
Support Company initiatives
Support Quality Management Systems
Support Environmental Management Systems
Support regulatory requirements
Comply with FDA regulations
Comply with other regulatory requirements
Comply with Company policies
Comply with operating procedures
Maintain positive communications
Maintain cooperative communications
Perform related duties
How You'll Work.
Team & Collaboration
Core Team Member; Multi-departmental project teams; Cross-functional teams
Communication Scope
Verbal communications; Written communications; Communicate at multiple levels
Process & Methodology
Project management, Leadership
Full Job Description
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 115,000 colleagues serve people in more than 160 countries. ## **JOB DESCRIPTION:** A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. We are seeking an experienced, high caliber **_Quality Engineer I_** for our **_Liberty, South Carolina_** location. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. **WHAT YOU’LL DO** \- Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements \- Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements \- Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues \- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues \- Design and conduct experiments for process optimization and/or improvement -Appropriately document experiment plans and results, including protocol writing and reports \- Lead process control and monitoring of CTQ parameters and specific
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