BD (Becton, Dickinson and Company) QA Specialist EMEA in Crawley, United Kingdom
Job Description Summary
A new and exciting opportunity for the position of Quality Specialist in EMEA has arisen.
Reporting to the Director Quality EMEA, the successful candidate will be supporting the development and implementation of BDI EMEA’s 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 position mainly focuses on and provides support to Quality Assurance and Quality Control activities related to Post Market Surveillance activities such as Vigilance Reporting.
As a Quality Specialist you will be focusing on the following tasks:
Support the process for submission of vigilance reports including the completion of the vigilance decision tree and refers complex reports to senior staff; supports the oversight and timely reporting of events, including metric generation and reporting.
Determine vigilance reportability based on an understanding of the risks associated with product malfunction and with senior staff.
Generate key QA EMEA metrics on weekly and monthly basis.
Strive to meet Accuracy Goals and delivers data in a timely manner. Ensures data is collected through routine business processes and reviewed by senior staff for accuracy, timeliness, relevance, completeness, comprehension, and quality.
Performs queries to provide complaint data and ad hoc trend analyses on reported product problems/complaints/ vigilance reporting and or other QA data.
Supports the EMEA complaint handling process and serves as back up for IBCs as defined.
Acts as formal back up for senior staff
Educated to a degree level with a proven track record in a quality or regulatory function within a medical device company (or regulated health industry) or the following industry sectors:
a) Post Market Surveillance
b) EU Medical Devices Directive
c) Quality Management
We are looking for a candidate with an in-depth understanding of requirements relating to (a) Quality Management Systems, in particular ISO 13485 and ISO 9001 and good understanding and knowledge of the Medical Devices Directive, 93/42/EEC, including post market surveillance activities.
The ideal candidate will have good analytical skills; attention to detail and ability to manage multiple tasks and priorities at the same time as well as strong interpersonal, collaboration and relationship-building skills at all levels and across all functions of the organization. You should be able to adapt to working as a part of an interdisciplinary team and skilled at negotiation and influencing others. In addition, you should have a proactive behavior, forward thinking and a passion for process management and driving efficiencies.
Interested in a career with BD, but this position doesn’t fit your skills and experience?
Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Primary Work Location
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.