BD (Becton, Dickinson and Company) Quality Engineer (m/w/d) IVDR / MDR - Heidelberg in Heidelberg, Germany
Job Description Summary
This position will lead and will be responsible for the gap assessment of the requirements for the new IVD products manufactured at BD Heidelberg as well as the implementation of remediation efforts.
We are open for applications in full-time and part-time (min. 50%).
If you are interested in this role, we are looking forward to your application in German.
- Implement the required quality system elements for compliance to EU IVDR requirements
Completion of gap analysis to new requirements
Creation and execution of Quality Plan to meet new IVDR requirements
Closure of Gaps identified wrt to IVDR
- Post Market Surveillance
Develop the post market surveillance process (PMS) in conjunction with clinical, laboratory, R&D, regulatory, marketing, medical affairs and Qualify functional representatives
Execute the post market surveillance process in support of EU IVDR, including routine communication with notified bodies
Presentation of PMS results to functional stakeholders and senior leadership
Follow up to ensure results are translated in to updates to risk management documentation and clinical evaluation reports as required
Notified Body Audit handling related to IVDR
Act as a technical expert for EU IVDR requirements in support global sites during external/internal audits
Develop training content and provide quality system related training's at unit and plant locations
Maintain and improve the unit and WW Quality System documentation
Assist with FDA , external and corporate audit readiness globally
Ensure quality system improvement and standardization initiatives with in the business are implemented
Provide guidance to the team on IVDR
You have a university degree in food technology, process engineering, biotechnology or a related field of study and at least 3 years of professional experience in the food processing, pharmaceutical or chemical industry. You have a qualification as certified QMB (Quality Management Representative) and a minimum of 2 years’ experience in quality management with focus on IVDR.
Further requirements are:
Good knowledge of IVDR/MDR
Good understanding of root cause analysis process, statistical tools and validations
Understanding of Quality Systems regulations
Good Knowledge of ISO:13485:2016
Very good knowledge of the common software applications (Access, Excel, Word, Power Point)
Ability to prepare and present data and their presentation and documentation
Fluency in German and English is a must
A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender.
Primary Work Location
DEU Heidelberg - Tullastrasse
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.