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Quality Engineer(Medical Devices)

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Pleasanton, United States of America
Salary undisclosed

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Job Title: Quality Engineer

Duration: 12+ Months

Location: CA

Responsibilities

  • Develop and integrate systems to support compliance and traceability requirements.
  • Lead quality planning and continuous improvement initiatives.
  • Implement and manage quality systems, software, and records.
  • Perform and oversee metrology and calibration activities.
  • Ensure adherence to AS9100 or similar quality systems.
  • Conduct advanced root-cause analysis and solve complex problems.
  • Apply Six Sigma methodologies to enhance processes.
  • Collaborate with cross-functional teams to drive quality improvements.
  • Provide expert knowledge on product manufacturing, inspection, and technology.
  • Maintain a strong understanding of process management, technical specifications, and regulatory guidelines.
  • Deliver clear and effective presentations on quality issues and improvements.

Education Requirements

  • Bachelor’s degree in Engineering or applicable science; Master’s degree is a plus.
  • Minimum of 5 years of experience with a Bachelor's degree or 2 years with a Master’s degree.

Desired Skills

  • Expertise in Quality Planning and Six Sigma.
  • Proficiency in quality software, systems, and records management.
  • Experience with Metrology and Calibration.
  • Familiarity with AS9100 or similar quality standards.
  • Advanced root-cause analysis and problem-solving skills.
  • Strong knowledge of product manufacture, inspection, and testing technologies.
  • Excellent presentation and communication skills.
  • Ability to independently develop solutions while adhering to policies.
  • Proven ability to work effectively in cross-functional teams.