Quality Assurance (QA) Specialist - Medical Device Manufacturing Job at Katalyst HealthCares and Life Sciences, Pleasanton, CA

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  • Katalyst HealthCares and Life Sciences
  • Pleasanton, CA

Job Description

Responsibilities & Requirements:

  • 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.
  • 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.
  • bility to work collaboratively with cross-functional teams and communicate effectively at all levels of the organization.
  • Proficient in using quality tools like Six Sigma, PFMEA, and statistical process control (SPC).
  • Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar certifications.

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