Abbott
Healthcare
SeniorQualityEngineer
“Senior Quality Engineer at Abbott. Skills: Quality Engineering, CAPA, Risk analysis, FMEAs. Ensure compliance with policies and procedures. Identify manufacturing process defects”
What You'll Achieve.
Reduce site non-conformance index year over year
Industry & Context.
Root cause analysis; Problem-solving; Troubleshooting
Keyboard use (greater or equal to 50% of the workday), 5% travel
What They're Looking For.
Must Have
Bachelor's degree in engineering, Minimum 5 years of experience, Relevant experience in Quality and/or Compliance, Knowledge of applicable US & non-US regulations, Knowledge and proficiency in Quality Engineering principles, Ability to lead cross-functional teams, Excellent written, verbal and interpersonal communication skills in Spanish and English, Ability to evaluate complex process, Ability to interact effectively with all levels
Nice to Have
Experience in medical device industry
What You'll Do.
Ensure compliance with policies and procedures
Identify manufacturing process defects
Disposition non-conforming material
Lead root cause investigations
Identify corrective and preventive actions
Train others in CAPA methods
Manage quality issues with minimal oversight
Communicate quality issues promptly
Keep management informed of investigation status
Lead line support team for triage
Determine if non-conformance impacts distributed product
Determine initial bracketing and containment
Initiate stop ship and escalation process
Report quality metrics
Develop product quality plans
Provide direction for product specifications
Provide direction for quality specifications
Provide direction for quality plans
Provide direction for risk analyses
Provide direction for FMEAs
Support internal and external audits
Own and maintain product risk analyses
Own and maintain FMEAs
Mentor others in risk management
Utilize process monitoring tools
Reduce process variation
Mentor and train others in SPC tools
Mentor and train others in process controls
Develop Quality Tools & Training Materials
Train others in prevalent tools
Train others in available training materials
Lead Product/Process improvement efforts
Gather quality metric data
Use analysis methods to enhance design
Support Divisional Product/Process improvement efforts
Enhance sustaining product design
Enhance new product development
Run complex problem-solving efforts
Mentor others on best practices
Implement complex changes through change management
Provide quality engineering impact assessment
Reduce site non-conformance index
Write protocols and reports
Support engineering studies
Develop complex test strategies
Summarize statistical data
Mentor others in best practices
How You'll Work.
Team & Collaboration
Cross-functional teams; Line support team
Communication Scope
Written communication; Verbal communication; Interpersonal communication
Process & Methodology
Change management
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