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
+353 (0) 71 9108062