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Quality Assurance Specialist

Katalyst Healthcares and Life Sciences
Pleasanton, CA Full Time
POSTED ON 1/22/2025
AVAILABLE BEFORE 4/13/2025

Responsibilities :

  • Excellent understanding of Quality Management Systems (QMS) and regulatory requirements in the medical device industry.
  • Strong problem-solving skills with a focus on root cause analysis, CAPA, and continuous improvement.
  • Ability to work collaboratively with cross-functional teams and communicate effectively at all levels of the organization.
  • Proficient in the use of quality tools such as Six Sigma, PFMEA, and statistical process control (SPC).

Requirements :

  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certifications.
  • Minimum of 4-6 years of experience in quality assurance within the medical device manufacturing industry.
  • Strong knowledge of validation protocol and other relevant medical device standards.
  • Experience with process validation, risk management, CAPA, RFA, and validation protocols in a manufacturing environment.
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