Quality Assurance Specialist

1 day ago


Vista, California, United States Enovis Full time
Job Overview: Enovis is seeking a Quality Assurance Specialist to join our team in Vista, California. This role will play an integral part in driving the medical technology industry forward through transforming patient care and creating better patient outcomes.

This position requires a bachelor's degree in Engineering or other technical discipline, as well as a minimum of 2 years of experience in quality engineering or related field. The ideal candidate will have knowledge of FDA/GMP, CMDR, MDD, and ISO 13485 quality standards, as well as expertise in process validations, product development supports, and Lean Six Sigma principles.

The salary for this position is estimated to be around $120,000 per year, based on industry standards and location. If you are passionate about quality assurance and committed to excellence, we encourage you to apply for this exciting opportunity

Key Responsibilities:
  • Preparation, implementation, and maintenance of Master Quality Plan.
  • Involvement in quality improvement facilitation by establishing methods of data collection, control charting, dimensional inspection, documentation, or other experimental design techniques.
  • Involvement on the Master Validation Plan (IQ, OQ, PQ) regarding validation and verification Processes.
  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.

Requirements:
  • Bachelor's degree in Engineering or other technical discipline.
  • Minimum 2 years of experience in quality engineering or related field.
  • Knowledge of FDA/GMP, CMDR, MDD, and ISO 13485 quality standards.
  • Expertise in process validations, product development supports, and Lean Six Sigma principles.


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