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Quality Assurance Specialist

2 months ago

Santa Clara, California, United States Intellectt Inc Full time

Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Quality Assurance Specialist with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to or reach out to me directly at.

Role: Quality Assurance Specialist

Location: Santa Clara, CA

Duration: 12 Months on W2

Job Overview:

We are looking for a proficient Quality Control Engineer to oversee and implement intricate quality assurance initiatives. This position entails the design and upkeep of quality programs, leading teams, and executing process enhancements to guarantee compliance with quality benchmarks.

Primary Responsibilities:

  • Manage and execute intricate quality assurance initiatives.
  • Formulate innovative solutions and modify existing strategies to fulfill project requirements.
  • Design and sustain programs for monitoring and assessing project quality.
  • Guide and mentor quality assurance professionals.
  • Conduct thorough analyses of quality records to propose enhancements.
  • Perform inspections, verifications, and validations of development components and materials.
  • Identify and resolve recurring quality challenges.
  • Document quality concerns and performance metrics for management review.
  • Collaborate with external vendors to ensure adherence to quality standards.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field, or equivalent experience.
  • 2-5 years of engineering experience with quality tools and methodologies.
  • Familiarity with FDA regulations, GMP, ISO 13485, and ISO 14971.
  • Strong communication, project management, and leadership skills.
  • Experience with Six Sigma and Lean Manufacturing methodologies.