Quality Assurance Manager
A fast-growing medical device company is looking for a Quality Assurance Manager to join their Frankfurt office. This organisation is the pioneers of new life changing therapies for heart failure. This is an exciting opportunity to make a change to the face of medicine.
- Assist in the development and authoring of quality system policy, procedures, and instructions.
- Assist Director, Quality Assurance with 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
- 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.
- Performs investigations of EU related non-conformances, customer complaints and corrective actions
- Manages device safety testing
- Liaison for Clinical Affairs with regards to Quality compliance information
- Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR Training
- Contact for the Regional Board
- Contact for BfArM (Federal Institute for Drugs and Medical Devices) and DIMDI (German Institute of Medical Documentation and Information)
Skills and Requirements
- 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
- Knowledge of Quality Management System
- Knowledge of European Medical Device Regulations
- Working knowledge of standards and regulations as outlined in the QMS documentation and structure
- Trained ISO 13485:2016 auditor preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.