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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.

Job Description

  1. 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

  1. 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

  1. General
  • 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

About You

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

Our Offer

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

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.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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