We are looking for an independent personality who enjoys working in a very dynamic environment.
Reporting to the Head of Research & Development and the Project Leader Anti Doping, you will be responsible for maintenance and further development of technical documentation & product files in R&D (Temperature Monitoring & Anti Doping) as well as monitoring of the product development process as quality engineer.
Your main tasks
- Support R&D create/maintenance/update of Technical Dossiers (TD), Technical Files (TF) and Design / Product History Files (DHF) according to applicable international regulations & standards
- Review design documentation (V&V, user needs, design inputs/outputs, claims, risk management)
- Assess impact of (and act upon) manufacturing or design changes or non-conformity on TF, TD & DHF
- Support implementation of appropriate controls to ensure product records are maintained/archived/updated to meet applicable record retention and regulatory requirements
- Support product change orders and new product development from a product compliance perspective, from feasibility up to commercialization and throughout the product lifecycle
- Work closely with multifunctional product development teams to ensure compliance with design control, safety, functional goals requirements with a customer-related focus in accordance with all applicable requirements (FDA, MDR, IVDR, GMP, WADA ISTI, IATA etc.)
- Interact with QMRA Specialists to identify regulatory pathways for certifications
- Provide expert guidance to R&D for the applicable standards and regulation (e.g. REACH, ISO 13485, FDA, GMP guidelines, WADA ISTI, IATA)
- Ensure conformity of all product labelling associated to the product (IFU, brochure, web, etc.)
- Manage product and process change control processes
- Pilot risk activities according to applicable requirements (ISO 14971)
- Support sites and group & regulatory bodies' audits & inspections regarding TD, TF and DHF
- Support the impact assessment of regulations and standards changes, CAPAs & NCs on the TD, TF & DHF
What we offer you
- Challenging, exciting and extremely varied field of activity with many opportunities for your further development
- Modern employment conditions
- Collaboration in a dynamic, open-minded team
- Possibility to work in a home office
- Staff restaurant at lunchtime
In this role within an international, world-renowned company, you will enjoy a high degree of flexibility and be able to make a decisive contribution to the realisation of the corporate vision. With its unique safety concept regarding the monitoring of medicine transports, Berlinger plays a significant role to always ensure impeccable drug quality. In addition to the modern and familiar working environment, a job at Berlinger impresses with this profound sense of purpose in the business field. Add a substantial part to ensure the high quality and development of the company in the future.
Extensive familiarisation with the new tasks and projects will prepare you optimally for your new field of activity. Take the opportunity to become part of our innovative Berlinger team and make your contribution to our road to success.
- Engineer with experience in QMRA as well as regulated environment
- M.S./B.S or similar in mechanical engineering, electrical engineering, SW or similar
- 1-5 years of experience in international multidisciplinary R&D or QA/RA organizations in the area of design control
- Knowledge in quality management standards (ISO 13485 and ISO 9001), risk management (ISO 14971) and GxP environment is an advantage
- Knowledge of the requirements of international standards according to IATA, GAMP 5,
- Very good analytical skills and a structured way of working
- Fluent in German and English
- Proactive team player with "can do" mentality
Ms Jeanette Slade, HR Specialist
Thank you for your application with photo by e-mail or apply directly on berlinger.com/jobs
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