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.

Job Responsibilities

• 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.

To Apply

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.

In case you have difficulty in applying or if you have any questions, please contact Olivia Anton on +44 203 856 9335 or upload your CV on our website - www.proclinical.com/send-cv

#Commercial

#LI-OA