Abbott
Healthcare
QualityEngineerI
“Quality Engineer I at Abbott. Skills: Quality engineering, Process control, CAPA systems. Identify and implement process control systems. Lead implementation of assurances”
Industry & Context.
Problem-solving methodologies; Root cause analysis
5% travel
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, Prior medical device experience, Experience implementing Six Sigma, Experience implementing Lean Manufacturing, ASQ CQE certification, Other certifications, Experience working in a broader enterprise model, Experience working in a cross-division business unit model
What You'll Do.
Identify and implement process control systems
Lead implementation of assurances
Lead implementation of process controls
Lead implementation of CAPA systems
Assist in development of business systems
Assist in execution of business systems
Apply problem-solving methodologies
Identify quality issues
Prioritize quality issues
Communicate quality issues
Resolve quality issues
Document experiment plans
Document experiment results
Lead monitoring of CTQ parameters
Lead monitoring of specifications
Lead product improvement methodologies
Lead process improvement methodologies
Lead investigation of non-conformances
Lead resolution of non-conformances
Lead prevention of non-conformances
Support quality disciplines
Support quality decisions
Support quality practices
Represent Quality function
Lead completion of risk analysis
Lead maintenance of risk analysis
Work with design engineering
Complete product verification
Complete product validation
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
Comply with processes
Comply with task assignments
Maintain positive communications
Maintain cooperative communications
How You'll Work.
Team & Collaboration
Core Team Member
Communication Scope
Verbal communications; Written communications
Process & Methodology
Project management, Leadership
Applying for this Quality Engineer I role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Abbott?
Real rants from real employees. Read before you apply.