BEBIG Medical GmbH is a global provider of high-quality radiation therapy  products headquartered in Berlin, Germany. Our core business is the  manufacture and distribution of products for the treatment of cancer using  brachytherapy - a form of treatment in which tumors are irradiated directly  on the surface of the body, in tissue or in body cavities using a radioactive  source.  Through punctuality, service character, consistently high quality, and  innovative products, we strive to meet the needs and expectations of our  customers as well as their patients. With a team of professionals and  offices in Europe, USA, and Asia, BEBIG Medical GmbH can serve  customers from more than 80 countries and regions.

Your Tasks:

• Review technical documentation (Design Dossiers, Risk Management, Product Verification & Validation, Process & Equipment Validation, Biocompatibility, Clinical evaluation, Post market surveillance) for compliance with applicable international standards (ISO 13485, ISO 14971, IEC 62366, IEC 62304, ISO 10993 series, etc.) and regulations EU MDR (and/or FDA 510(k)) as defined by the company conformity assessment strategy

• Check the content of the above-mentioned technical documentation for adequacy, consistency, cross-alignment, sufficiency of detail and clarity for external reviewers (e.g. by notified body, authority)

• Support creation of technical documentation and quality process documentation within the responsibility of Quality Department (labelling specifications, QA inspections forms, validation master plans) and provide other quality input during the product development

• Ensure maintenance of the technical documentation throughout product life cycle in a transparent and audit-ready way. Participate in internal and external audits representing the Quality function in the R&D process

• Assist with answering questions or resolving non-conformities from the notified body/authority to the technical file from the Quality function

• Verify that design phases and design controls are properly followed and documented in accordance with internal SOPs. Support continuous improvement of the RD processes and technical documentation templates

• Plan and organize Change Board meetings and control implementation of product change requests

• Work closely with Research and Development, Product Management, Production and Regulatory Affairs, within medical device projects (medical device hardware and software) 

Your Profile:  

• Bachelor’s degree in biomedical engineering or alternative life - science bachelor’s degree

• Several years of work experience in medical device quality management or engineering with technical documentation.

• Strong knowledge of ISO 13485 and EU MDR 2017/745. Knowledge of other relevant standards and regulations is a plus

• Good skills with MS Office applications

• Excellent written and verbal communication skills in German and English

• Ability to assist multiple development projects (cross-company in BEBIG Medical group) and manage deadlines in a structured manner

• Quick learner and team player, with high attention to detail, good analytical and problem-solving skills and risk-based thinking

What we offer:   

• Family-friendly orientation with flexible working hours

• Performance-related remuneration

• Opportunities for further qualification

• Pleasant working atmosphere in a committed team 

• Flat hierarchies and short decision-making processes

• Parking facilities and good public transport connections

Have we aroused your interest? Then we are looking forward to receive your application in English, please kindly send your CV to: hr@bebigmedical.com.
Ideally, please send your informative application  documents  by e-mail and all documents summarized in one file (PDF), stating your salary expectations and the earliest possible starting date