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Quality Systems Training Specialist : 17-02656
Ref No.: 17-02656
Location: Sunnyvale, California
Primary Skills : Creation and maintenance of new training curricula/training plans per core function and Quality System requirements
Location :  Sunnyvale, CA
Duration : 12+ Months
Tax Term : W2 Only

Position's Objective & Summary :
  • As a key member of Quality System and Compliance (QSC) department, the Quality System Training Specialist is responsible for the development, management and continuous improvement of company's Training Program processes.
  • The Quality System Training Specialist helps lead the Quality Systems training function by interfacing with all functions that have internal Quality System training needs associated with compliance for their respective function(s).
  • The role is responsible for executing efforts to improve the design and delivery of the Global Quality System training strategy.
  • This cross functional role works on the creation, tracking, and management of the training process and delivery of training events utilizing internal or external resources.
  Preferred Knowledge, Skills, and Experience :
  • Proficiency with BOXI application report generation and SAP is desired.
  • Experience with an Automated Change Control System (ACCS), preferably Agile (Oracle).
  • Experience generating, interpreting, and presenting training metrics.
  • Experience in providing accurate training data in the support of internal and external audit requests
  • Creation of Computer Based Training (CBT) material.
  • Adept at educating others on the quality system training requirements according to established procedures.
Required Knowledge, Skills, and Experience :
  • Four year college degree, education and/or training certification or equivalent experience.
  • Minimum of 2 to 4 years training experience in a regulated industry; US Medical Device and/or Pharmaceutical industry.
  • Experience in the deployment, maintenance, and improvement of a company-wide training system.
  • Demonstrated proficiency with a Learning Management System (LMS) (e.g., Success Factors).
  • Ability to communicate training requirements and information at multiple levels (e.g., technician to management).
  • Proficient in interpreting training requirements to comply with the FDA regulation and international standards.
  • Experience with working with processes associated with GDP (Good Documentation Practices, GMP (Good Manufacturing Practices), especially pertaining to training, quality records, and training process improvements.
  • Excellent interpersonal and communication skills with the ability to negotiate and influence others.
  • Strong organizational skills with attention to detail; excellent English written and verbal skills.
  • Possess autonomous attributes to ensure the ability to manage own time and projects.
  • Demonstrated experience in creating and running data summary reports.

  Please apply directly with your updated resume or call Surbhi at # 408-512-2359