1+ months
2018-05-112018-07-20

Quality Engineer

Abbott
Santa Clara, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Primary Job Function.  

Provide Process/Quality Engineering support on quality system improvements.  Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. 

Core Job Responsibilities Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1.  Responsible for creating engineering protocols and reports, including statistical analysis of data. Participating in efforts/teams focused on 

identifying the primary root causes and implementing corrective and preventative actions. 

2. Develops product quality plans, documents and systems by creating product 

specifications, quality specifications and quality plans in conjunction with other 

product development team members. May be responsible for creating risk 

analyses and FMEAs.; 

3. Develops Process Monitoring Systems by identifying critical process steps 

applying methods to reduce process variation in order to reduce/eliminate the 

cause of defects.; 

4. Leads process improvement efforts by identifying methods to capture quality 

metric data and by performing appropriate analysis methods to enhance 

sustaining product design and new product development.;  Leads process improvement efforts on quality systems and integrating compliance with regulatory requirements.

5. Assists in creation of Quality Tools & Training Materials by understanding 

the limitations of existing quality tools and training materials, and by helping to 

identify more effective tools & materials.

Supervisory / Management Responsibilities (Supervision Received) Works under general supervision. Follows established procedures. Work is reviewed for soundness of technical judgment, overall 

adequacy and accuracy.; 

(Supervision Provided) May provide limited work direction and guidance to exempt and/or skilled nonexempt levels 

of employees; may be asked to evaluate performance of and assist in career 

development planning for subordinates.

Position Accountability / Scope (Influence/Leadership) Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion 

of tasks.  May lead a project team of moderate scope. Provides guidance to 

less experienced staff. Acts as a mentor to lower level individual contributors. 

Influence exerted at peer level and occasionally at first levels of management.; 

(Planning/Organization) Plans, organizes, and prioritizes own daily work routine 

to meet established schedule.;

(Decision Making/Impact) Exercises authority and judgment within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations 

may cause delays in program schedules and may result in the allocation of 

additional resources.

Minimum Education

Bachelor's degree plus 2-5 years of related work experience with a good 

understanding of specified functional area, or Master's degree with 0-2 years of 

related work experience, or an equivalent combination of education and work experience.

Minimum Experience / Training

(Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures.  General understanding of 

business unit/group function. Will perform this job in a quality system 

environment.  Failure to adequately perform tasks can result in noncompliance 

with governmental regulations.; 

(Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.  Exercises judgment 

within defined procedures and practices to determine appropriate action. Has 

a broad knowledge of technical alternatives and an understanding of their 

impact on the systems environment.

Preferred experience:

  • CAPA
  • JMP/Statistical Analysis
  • Procedure Writing
  • New Product Development
  • Medical Device Quality System

    NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION.

    OPEN TO CONSIDER CANDIDATE AT A LOWER LEVEL.
    Job Family: Operations Quality
    Division: AVD Vascular
    Travel: Yes, 10 % of the Time
    Medical Surveillance: Yes
    Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Quality Engineer

Abbott
Santa Clara, CA

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Abbott
Santa Clara, CA
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