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Abbott · 6 hours ago

Quality Engineer II

Menlo Park, CA

Full-time

Onsite

Entry, Mid Level

$82K/yr - $141K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. As a Quality Engineer II, you will provide Process/Quality Engineering support to manufacturing and product development teams to ensure the delivery of the highest quality products. Your role involves identifying manufacturing process defects and supporting continuous improvement efforts.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Learns to identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions

May be responsible for working with process owner to bound product stops and document release criteria

Gains understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems

Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps. and through familiarization with methods used to reduce process variation

Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development

Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials

Begins developing a network of internal resources to facilitate completion of tasks

Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks

May exercise authority within pre-established limits and approval

Failure to achieve results can normally be overcome without serious effect on schedules and programs

May be responsible for working with process owner to bound product stops and document release criteria

Gains understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems

May be responsible for learning risk analyses and FMEAs

Learns Process Monitoring Systems by becoming familiar with systems applications and critical process steps. and through familiarization with methods used to reduce process variation

Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials

Begins developing a network of internal resources to facilitate completion of tasks

Individual influence is typically exerted at the peer level

Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks

May exercise authority within pre-established limits and approval

Failure to achieve results can normally be overcome without serious effect on schedules and programs

Qualification

Quality EngineeringMedical Device ExperienceFDA KnowledgeGMP KnowledgeISO 13485ISO 14971CAPA ManagementRisk ManagementPost Market SurveillanceManufacturing AnalysisProcess ImprovementTechnical KnowledgeSoft Skills