Description
Medical Device Product and Quality System Documentation Support (m/f)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Support the Product Care Leaders in establishing and preparing Quality System Documentation and maintain Technical Documentation according requirements outlined in the Medical Device Directive and 21 CR820 for Medical Devices and Design History Files
- Support for annual Product Care, Product Review including Device Risk Management Activities
- Support for Change Assessments and Change Implementation
- Product Care Team Meeting organization, preparation, writing minutes and tracking action items
- Actively contribute to improvement of documentation management systems, business processes and procedures, ensure Good Documentation Practices
- Perform any other tasks as requested by Management to support Documentation and Compliance activities
- Being part of a 7 people team under the supervision of a Product Care Leader and the guidance of the team members
- Close collaboration with internal and external stakeholders such as Quality functions, Manufacturing units, etc.
Main qualifications
- Experience in working in pharmaceutical, biotech, diagnostics, medical device or healthcare industry under cGxP, QSR or similar working practices
- Excellent documentation and interpersonal communication skills
- Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing
- Team player with excellent collaborative skills, flexible, versatile and inquisitive, analytical, with attention to detail
- Excellent IT knowledge (Excel, etc.)
- Preferable Trackwise QMS Software experience
- Excellent language skills in German and English
Main advantages:
- A city with a high quality of life that perfectly embraces both modern and traditional values
- Flat hierarchies
- Pleasant working atmosphere
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Sonja Lentz
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