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Quality Engineer

TekOne IT Services Pvt. Ltd.
Santa Clara, CA Full Time
POSTED ON 12/15/2024
AVAILABLE BEFORE 2/11/2025
Hello Everyone,

Greetings of the day.

This is Vydehi from Intellectt Inc. We currently have an opening for a Quality Engineer 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 vydehi@intellectt.com or reach out to me directly at 1 732 355 7412.

Role: Quality Engineer

Location: Santa Clara, CA

Duration: 12 Months on W2

Job Summary

We are seeking a skilled Quality Engineer to manage and execute complex quality assurance projects. This role involves designing and maintaining quality programs, leading teams, and implementing process improvements to ensure quality standards are met.

Key Responsibilities

  • Oversee and execute complex quality assurance projects.
  • Develop innovative solutions and adapt existing approaches to meet project needs.
  • Design and maintain programs for monitoring and evaluating project quality.
  • Lead and mentor quality assurance professionals.
  • Conduct in-depth analysis of quality records to recommend improvements.
  • Perform inspections, verifications, and validations of development components and materials.
  • Identify and address recurring quality issues.
  • Document quality issues and performance measures for management review.
  • Liaise with external vendors to ensure 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.
  • Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
  • Strong communication, project management, and leadership skills.
  • Experience with Six Sigma and Lean Manufacturing methodologies.

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