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Company: Varian Medical Systems
Location: Palo Alto, CA
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

We currently have an opportunity for a Quality Assurance Engineer for our Palo Alto facility. In this key role, the Quality Assurance Engineer will manage implementation, support, and maintenance of company-wide quality objectives, including analysis and trending of key quality system elements on a periodic basis. Additional duties to include:

  • Manage the CAPA program; review root cause analysis and proposed corrective actions; track the implementation and effectiveness of committed corrective and preventive actions
  • Analyze data to discover and interpret trends, patterns, and relationships
  • Create dashboards and reports to communicate actionable data
  • Review data quality and provide guidance and controls to upstream data providers and sources


Requirements

  • Bachelor's degree (or equivalent experience) and 5 years of related experience or Master's Degree with 3 years of related experience.
  • Experience with an electronic CAPA system
  • Prior experience working in a medical device company
  • Experience with regulatory and compliance
  • Familiarity with FDA Regulations, ISO 13485, GDP, GMP
  • Positive, results-oriented and energetic team player
  • Highly analytical and quantitative, with strong attention to detail
  • Self-starter with excellent written, interpersonal and communication skills
  • Must be flexible with a sense of urgency
  • Ability to work independently and collaboratively
  • Ability to prioritize and manage to critical project timelines
  • Must be able to handle multiple responsibilities concurrently
  • Must be organized, have an eye for detail, and be able to put ideas into a tangible form
  • Logical and organized thought pattern
  • Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint. Experience with SAP or equivalent ERP product and productivity software desired.


 Apply on company website