QA Manager - Germany
Excellent opportunity for QA Manager to join a multinational Medical Devices company based in Frankfurt, Germany. The role is responsible for providing technical leadership in establishing, implementing, and maintaining quality system processes and documentation in compliance with domestic and international regulatory/quality requirements.
Overview of your responsibilities (full job description available on request)
- 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 (inspection, labelling, inventory tracking)
- Manages the preparation and assists with the execution of external and internal audits.
- EU Complaint Coordinator: ensure proper completion of US field complaints, complete complaint investigations and report adverse events to regulatory to ensure timely reporting to regulatory authorities.
- Contact for BfArM (Federal Institute for Drugs and Medical Devices) and DIMDI (German Institute of Medical Documentation and Information)
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
- Proficient in German and English
For a confidential discussion and more information on the role contact Priti Mudgal
+353 (0) 71 9108064