Job Description:

• Skills Required:
  • Preferred experience with Creo.
  • Change management experience with Agile.
  • Proficiency in Minitab or similar data analysis tools.
  • Strong understanding of statistical techniques and analysis.
  • Knowledge of FDA, ISO 13485, EU MDR, or applicable medical device regulations.
  • Experience in process validation (IQ/OQ/PQ) and test method validations.
  • Background in the medical device industry.
  • Strong interpersonal skills and the ability to work in a cross-functional team environment.
  • Excellent communication, documentation, and writing skills.