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Quality Assurance Specialist

2 months ago

Santa Clara, California, United States LanceSoft, Inc. Full time

Key Responsibilities:

  • Possess a solid understanding of engineering principles within the Biomedical or Manufacturing sectors.
  • Exhibit meticulous attention to detail in all tasks.
  • Adapt to rapidly changing priorities while managing multiple tasks effectively.
  • Generate Non-conformance Reports as necessary.
  • Engage in Quality Performance Indicator (QPI) documentation.

Qualifications:

  • Bachelor's degree in Engineering or a related Technical Field, or equivalent professional experience; 2-5 years of relevant experience preferred.
  • Proven engineering experience with a demonstrated application of Quality tools and methodologies.
  • Comprehensive understanding of regulatory standards including FDA, GMP, ISO 13485, and ISO 14971.