Abbott
Healthcare
SeniorQualityEngineer
“Senior Quality Engineer at Abbott. Skills: Quality Engineering, Process defect identification, Root cause analysis. Ensure delivery of highest quality product. Identify manufacturing process defects”
What You'll Achieve.
Reduce site non-conformance index year over year
Industry & Context.
Root cause analysis; Problem-solving
Onsite position, 5% travel, Keyboard use (>=50% workday)
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 effectively 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, Digital skills, Microsoft office
Nice to Have
Experience in medical device industry
What You'll Do.
Ensure delivery of highest quality product
Identify manufacturing process defects
Disposition non-conforming material
Lead identification of primary root causes
Identify appropriate corrective and preventive actions
Train others in effective CAPA methods
Manage quality issues of moderate to high complexity
Ensure prompt communication of quality issues
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
Lead team in developing product quality plans
Provide direction for setting product specifications
Provide direction for setting quality specifications
Provide direction for setting 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 process
Utilize process monitoring tools
Understand process shifts
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 use of prevalent tools
Train others in available training materials
Lead Product/Process improvement efforts
Systematically gather quality metric data
Use appropriate analysis methods
Enhance sustaining product design
Support Divisional Product/Process improvement efforts
Understand current quality metric data
Enhance new product development
Run complex problem-solving efforts
Mentor others on best practices
Implement complex changes through change management system
Provide quality engineering impact assessment
Reduce site non-conformance index
Write protocols to support engineering studies
Write reports to support engineering studies
Write protocols to support validations
Write reports to support validations
Develop complex test strategies
Summarize statistical data
Mentor others in best practices
How You'll Work.
Team & Collaboration
Cross-functional teams
Communication Scope
Written communication; Verbal communication; Interpersonal communication
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