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QA Manager

  • Sector: Medical Devices
  • Contact Email: courtney.russell@collinsmcnicholas.ie
  • Job Ref: 18093

Excellent opportunity for a QA Manager to work for a Global Medical Devices company based in Germany. This will be providing technical leadership around quality system processes and documentation in compliance with domestic and international regulatory/quality requirements. This will also be responsible for serving as the EU Representative for the company.

Overview of your responsibilities (full job description available on request)

  • Assist in the development and authoring of quality system policy, procedures, and instructions.
  • Assist QA Director with the management of multiple Quality Management System functions.
  • Oversees the day-to-day operations of the Quality Management System in EU.
  • Audits and collaborates with the contract logistics supplier in the EU to ensure quality control of incoming product and outgoing shipments
  • Manage the preparation and execution of external and internal audits.
  • EU Complaint Coordinator: complete complaint investigations and report adverse events to regulatory.

Knowledge, Skills and Experience Required for the Role:

  • BS in Engineering or Life Science Field required.
  • 5-10 years of QA/RA experience in a regulated environment (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP)
  • Knowledge of European Medical Device Regulations and ISO Standards
  • Knowledge of Quality Management System

For a confidential discussion and more information on the role contact Courtney Russell

courtney.russell@collinsmcnicholas.ie

+353 (0) 71 9108062