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Quality Assurance Manager Dutch Operations

2 maanden geleden

Varsseveld, Gelderland, Nederland Ecolab Voltijd

Job Description: We are seeking a highly skilled Quality Assurance Manager to oversee the Quality Management System for our Dutch operations.

Key Responsibilities:

  • Implement and maintain the Quality Management System in line with ISO 13485 and FDA 21 CFR Part 820 requirements.
  • Manage the QA department annual budget and support in the preparations and upkeep of technical files for each product family.
  • Support the Regulatory Affairs function in the registration process of Medical devices in different countries and coordinate Risk Management activities for the Dutch operations product families.
  • Lead QA projects and participate in cross-functional teams, ensuring timely and orderly completion of tasks.
  • Oversee the internal audit process and participate in investigations on complaints, ensuring resolution of quality-related issues.
  • Ensure completion of monthly Plant scorecard indicators and perform Management review in line with European quality management systems procedures.
  • Support continuous improvement and ensure the training program and processes are in line with our Quality Culture.
  • Manage Quality Management System audits conducted by the Notified body and Customers.
  • Support product development, product modifications, equipment, and process validations.
  • Manage the change control process and ensure batch documentation for the Varsseveld products are complete and reviewed.