BD (Becton, Dickinson and Company) QA Specialist, Benelux in Olen, Belgium

Job Description Summary

Reporting to the Director Quality EMEA, the successful candidate will be in charge for the development and implementation of Quality Management Systems and programs to ensure compliance with company policies and procedures and industry regulations and standards, including EU MDD 93/42/EEC and ISO 13485/ 9001. The employee will be the Benelux local QA head for Quality Assurance and Post Market Surveillance activities such as complaint handling and customer inquiries. This role will also be in charge of Benelux Regulatory Authority reporting requirements for medical devices in accordance with local and European regulatory requirements. He / She is also involved with management of notifications to the national Regulatory Authorities and reimbursement authorities in the Benelux.

Job Description

This role has three main objectives:

Ensuring compliance with Quality Assurance requirements in accordance with the Medical Devices Directive (new MDR). Management of complaint handling and vigilance reporting activities in accordance with regional and local regulatory requirements, including preparation and submission of Vigilance Reports, management of Hold notifications and field actions, communications with customers and Regulatory Authorities and collaboration with US Source Divisions and manufacturing facilities Management and execution of quality and regulatory requirements in accordance with established procedures to release and launch products into the Benelux region

This role has three main objectives:

Ensuring compliance with Quality Assurance requirements in accordance with the Medical Devices Directive (new MDR). Management of complaint handling and vigilance reporting activities in accordance with regional and local regulatory requirements, including preparation and submission of Vigilance Reports, management of Hold notifications and field actions, communications with customers and Regulatory Authorities and collaboration with US Source Divisions and manufacturing facilities Management and execution of quality and regulatory requirements in accordance with established procedures to release and launch products into the Benelux region

Primary Work Location

BEL Olen

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.